Sklice

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Sklice

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Sklice

Quick Facts

Property Description
Active ingredient Ivermectin
Form Lotion (Topical preparation)
Pharmacological class Anti-parasitic agent (Endectocide)
Common use Treatment of external parasitic infestations
Origin Semi-synthetic

Sklice: Definition and Classification as a Pediculicide

Sklice is a prescription medicine categorized as an anti-parasitic agent, classified as a specialized pediculicide designated for external use. This definition establishes Sklice as an ectoparasiticide, a drug type that exclusively targets organisms residing on the surface of the body. The specific formulation is a key differentiating factor, positioned for use in both adults and children aged six months and older. Ivermectin lotion is recognized for its safety profile and its use as a tool for resolving common parasitic infestations.

Composition and Origin: The Role of Ivermectin

The foundation of Sklice is the active ingredient, Ivermectin, which is a semi-synthetic compound derived from the avermectin family. Sklice is formulated as a topical preparation in the form of a lotion, which is a single-ingredient product delivered via a specialized liquid formulation. This specific topical route of administration ensures the active agent is concentrated directly on the skin's surface. The compound provides targeted action against external pests, a characteristic that is clinically recognized within the medical community. Ivermectin is identified within the pharmacological class of Endectocides, which indicates its broad-spectrum ability to target external pests.

General Purpose of Sklice

The general purpose of Sklice is to effectively neutralize and eliminate external parasitic organisms through a targeted biological process. The drug is typically employed when a need arises for a potent agent to manage a localized external infestation in a way that minimizes systemic exposure. The potent pharmacological class and specialized lotion form contribute to its general therapeutic purpose of resolving the parasitic condition by rapidly eliminating the presence of the organism itself.

Regulatory References

  1. National Library of Medicine

What side effects are possible with Sklice?

Possible Side Effects and Safety Information: Sklice

Sklice (ivermectin) lotion has a safety profile primarily characterized by adverse reactions that are localized to the skin and eyes, consistent with its topical route of administration. All safety classifications are based on formal regulatory documentation.


Adverse Reaction Scope

Category Officially Documented Observations
System-Organ Classes Skin and subcutaneous tissue disorders (e.g., dry skin, skin burning sensation, contact dermatitis, dandruff) and Eye disorders (e.g., conjunctivitis, ocular hyperemia, eye irritation).
Frequency Classification The most common adverse reactions reported in clinical trials, such as dry skin, skin burning sensation, and conjunctivitis, occur at a low incidence (less than one percent) of treated subjects.
Serious Adverse Reactions The pivotal clinical trials reported no serious adverse events related to the drug. Potential severe allergic reactions or hypersensitivity are a general possibility with any medication.

Population-Specific Safety Considerations

Safety and effectiveness have been established for pediatric patients 6 months of age and older. Use is not recommended in children under 6 months of age due to the potential for increased systemic absorption and toxicity stemming from an immature skin barrier and a high ratio of skin surface area to body mass. For pregnant or lactating women, regulatory data are insufficient to determine a definitive drug-associated risk, necessitating caution.


Safety-Related Restrictions

Sklice lotion is for use on the hair and scalp only. A core safety constraint is the necessity to avoid contact with the eyes and other mucous membranes, as ocular contact is associated with adverse effects like conjunctivitis and eye irritation. To mitigate the risk of ingestion, the lotion must only be administered to children under the direct supervision of an adult.

Overdose and Emergency Response

Overdose and When to Seek Help

The official overdose profile for Sklice (ivermectin lotion) primarily concerns the systemic toxicity that can result from accidental oral ingestion of the topical preparation. The documented management strategy is strictly symptomatic and supportive, as regulatory guidance confirms that no specific antidote is known or available.

Domain Official Regulatory Statement
Documented Manifestations Systemic symptoms include nausea, vomiting, diarrhea, headache, dizziness, weakness, and rash. Neurological manifestations such as confusion, problems with coordination (ataxia), and seizure are documented.
Severe Outcomes High systemic exposure may lead to profound Central Nervous System (CNS) depression, respiratory failure, severe hypotension, and coma.
Immediate Action If accidental ingestion is suspected, contact the Poison Control Center immediately. Call emergency services (911) if the individual has collapsed or is not breathing.
Population Risk Pediatric patients under six months of age are noted to have an increased risk of toxicity due to potential systemic absorption associated with a high skin surface area to body mass ratio.

The regulatory documentation mandates that immediate medical attention must be sought for any suspected overdose. Supportive care, as described in prescribing information, involves measures such as administering parenteral fluids and electrolytes, providing necessary respiratory support, and using pressor agents for managing circulatory complications like hypotension.

Therapeutic Uses of Sklice

Quick Facts: Sklice

  • Primary Use: Treatment for infestations of head lice.
  • Therapeutic Population: Patients 6 months of age and older.

Sklice (ivermectin) lotion is indicated for the topical management of head lice infestations (Pediculus capitis) on the hair and scalp. This condition is a common parasitic concern that requires targeted treatment for resolution.

The medication is a pediculicide and is approved for use in adults and children 6 months of age and older. It offers a specific approach to address the presence of live lice on the scalp. The application is typically designed to work as a single intervention, which may help to resolve the infestation in most patients. As with all treatments for this condition, Sklice should be utilized as part of a comprehensive lice management program.

This program typically includes washing or dry-cleaning all recently worn clothing, bedding, and towels, as well as washing personal care items like combs and brushes in hot water to limit the potential for recurrence. The efficacy and safety of Sklice for its indicated use are established features of the medication.

Eligibility and Restrictions for Use

The eligibility for using Sklice (ivermectin) topical lotion is strictly defined by regulatory documents, focusing primarily on age and the site of application.

Populations Allowed and Restricted from Use

Classification Eligible Population Restriction/Exclusion
Minimum Age Patients 6 months of age and older. Not recommended for children under 6 months old due to the potential for increased systemic absorption and a higher risk of toxicity in infants.
Application Site Scalp and scalp hair only. Do not use near the eyes, or inside the nose, ear, mouth, or vagina. The product is not for oral, ophthalmic, or intravaginal use.
Contraindications No pre-existing conditions are documented as an absolute prohibition of use (no formal contraindications are listed in the FDA label).

Pregnancy and Lactation Status

Formal studies have not been established to determine the safety and effectiveness of Sklice in pregnant women. Caution should be used when administering the lotion to a nursing woman; she should be advised to avoid accidental transfer of the lotion to the breast area where the infant might directly ingest the drug.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction profile for Sklice (ivermectin) lotion, 0.5%, based strictly on governmental regulatory labeling. The regulatory documents for this topical medication do not contain a dedicated Drug Interactions section.

Sklice is a single-use topical preparation, and clinical studies indicate that systemic exposure following application is minimal. This profile accounts for the lack of formal interaction documentation.

Official Regulatory Status of Interactions

Interaction Type Regulatory Status (Based on Official Labels)
Drug–Drug Interactions None are formally documented in the label.
Contraindicated Combinations The official prescribing information lists No Contraindications regarding co-administration with other products.
Drug–Food / Drug–Substance Interactions No interactions with food, alcohol, or herbal products are documented.
Timing Requirements No mandatory timing separation rules are required between Sklice and co-administered medicinal products.

No officially classified pharmacokinetic interactions, such as those mediated by CYP enzymes, are documented for Sklice lotion. The constraints on co-administration are officially none, which reflects the regulatory authority's determination that the medication’s low systemic absorption profile does not lead to clinically relevant interactions with other medicines or products.

Mechanism of Action

Selective Targeting of Invertebrate Ion Channels

The active agent operates by binding to and activating Glutamate-gated Chloride Channels ( GluCls). These channels are specific to the nerve and muscle cells of invertebrate parasites and are absent in mammals. The molecule acts as an allosteric modulator, causing the GluCl channel to open and become irreversibly activated, thus bypassing the parasite's normal electrical controls. This mechanism ensures the drug's action is confined to the parasite's biology, limiting the physiological impact on the host's nervous system.


The Cascade of Hyperpolarization and Neuro-Muscular Blockade

The sustained activation of GluCls initiates a critical cellular cascade where massive amounts of negatively charged chloride ions ( Cl^-) flood the parasite's cells. This profound ionic shift leads to extreme hyperpolarization of the cell membrane, which instantly suppresses the ability of the parasite's nerve and muscle cells to generate action potentials or transmit signals. This hyperpolarization-induced motor failure is distinct from mechanisms that cause spastic paralysis, leading instead to electrical silencing.


Functional Failure and Flaccid Paralysis

The widespread neuro-muscular blockade specifically impacts the somatic muscles responsible for locomotion and the pharyngeal muscles necessary for nutrient intake. The resulting electrical silence causes the inability of the organism to move or feed, resulting in rapid flaccid paralysis. This combined physiological consequence—immobilization and cessation of nutrient intake—represents the final stage of the drug's mechanistic sequence, leading to systemic physiological failure. The mechanism may be constrained if parasites develop molecular alterations in their GluCl receptor, which reduces the drug's binding affinity.

Dosage and Administration Information

How to Use Sklice (Ivermectin) Lotion 0.5%

Sklice is a prescription medication for the topical treatment of head lice infestations in patients six months of age and older. The correct administration of Sklice involves a single-use application with adherence to specific procedural steps.

Official Administration Protocol

Procedural Step Instruction Detail
Preparation Hair and scalp must be dry before applying the lotion.
Dosing Apply an amount sufficient to thoroughly coat the hair and scalp, using up to one entire 4 oz tube.
Application Area The entire head must be covered, ensuring hair is coated from the scalp to the ends.
Contact Time The lotion must be left on for exactly 10 minutes; a timer should be used.
Rinsing After 10 minutes, rinse the product off completely using water only.
Aftercare Do not shampoo the hair for 24 hours after the application.
Frequency Sklice is a single-application treatment. Re-treatment is not routinely necessary and should only be done under the direction of a healthcare professional.
Age Restriction Indicated for use in patients 6 months of age and older. Use is not recommended for children younger than 6 months.
Safety Note Avoid contact with eyes; if contact occurs, flush with water. Hands must be washed after use.

This protocol defines the entire course of use for Sklice lotion. Users must apply the product strictly according to these time-bound, topical conditions and must discard any unused portion after the treatment.

Recent Clinical Evidence

Sklice: Recent Clinical Evidence

Efficacy in Head Lice Infestation

The efficacy of Sklice (ivermectin 0.5% lotion) was primarily evaluated in two identical, multi-center, randomized, double-blind, vehicle-controlled Phase 3 clinical trials. These studies enrolled patients, including children, six months of age and older with active head lice infestation. Participants received a single, 10-minute topical application of the lotion or a placebo (vehicle control).

Efficacy was defined as the proportion of subjects who were free of live lice at day 2 and through day 14 post-treatment. Key findings from these pivotal studies are summarized below:

Outcome Measure Treatment Group Lice-Free Rate (Day 14)
Pivotal Study 1 Ivermectin 0.5% 76.1%
Vehicle Control 42.9%
Pivotal Study 2 Ivermectin 0.5% 71.9%
Vehicle Control 38.4%

Safety and Systemic Absorption

The safety profile was assessed across all clinical trials, which included over 780 subjects. The topical lotion was generally well tolerated within the study populations. Adverse reactions reported in the trials were typically mild and occurred in less than 1% of treated subjects. The most commonly reported adverse reactions included conjunctivitis, ocular hyperemia (eye redness), and eye irritation.

Pharmacokinetic data from studies involving subjects as young as 6 months of age indicated very low systemic absorption of ivermectin following the recommended 10-minute topical application.

Frequently Asked Questions (FAQ)

Common questions about Sklice (FAQ)

Q: Is Sklice the same medicine now that it is available without a prescription?

Sklice (ivermectin) 0.5% lotion was approved by the U.S. Food and Drug Administration (FDA) for non-prescription (OTC) use in October 2020. The medicine remains indicated for the topical treatment of head lice infestations in patients who are 6 months of age and older. This change in status means the product is now available over the counter, while its core function and safety profile are consistent with its regulatory approval.

Q: Does Sklice kill lice eggs (nits) or just the adult lice?

Studies and official product information indicate that Sklice is formulated to kill both lice and their eggs (nits) on the scalp and hair. The active ingredient works through a specific paralyzing mechanism of action that targets the parasite’s biology. This targeted effect is described as eliminating organisms at both the adult and egg stages.

Q: Why do official documents state Sklice is for topical use only?

Regulatory documents strictly specify that Sklice is for use on the scalp and scalp hair only and is not for oral, ophthalmic (eye), or intravaginal use. Regulatory classification establishes this as a strict constraint, as getting the lotion in the eyes can cause irritation. Official labeling requires the product be administered to children only under the direct supervision of an adult to mitigate the risk of accidental ingestion.

Q: Is Sklice considered appropriate for use during pregnancy?

According to the official product information, no human studies have been conducted to determine the safety and effectiveness of Sklice in pregnant women. Given the drug’s minimal systemic absorption following topical use, the risk of fetal harm is not expected, but caution is still advised. The determination of use during pregnancy is a matter for consultation with a healthcare professional.

Q: Does the active ingredient in Sklice pass into breast milk after topical application?

It is not known if the active ingredient in Sklice is present in human breast milk following its topical application. However, regulatory information confirms that the systemic exposure from the topical lotion is much lower than that from oral medication. Official guidance notes that accidental transfer of the product to the breast area, where the infant might directly ingest it, should be avoided.

Q: Are there any specific symptoms that indicate a potentially severe reaction to Sklice?

The pivotal clinical trials reported no serious adverse events related to Sklice, and most side effects are localized to the skin and eyes. However, potential severe allergic reactions or hypersensitivity are possible with any medication. Official documents describe that in the event of difficulty breathing, persistent eye or scalp irritation, or a severe rash, cessation of use and consultation with a healthcare professional are indicated.

Q: Is it necessary to use a fine-toothed comb to remove nits after using Sklice?

The official instructions for Sklice state that nit combing is not necessary for the treatment to successfully work. The drug's effectiveness is established by being free of live lice after a single application. Nonetheless, if a user wishes to remove the remaining dead lice and nits, a fine-toothed comb may be used.

Q: Can one tube of Sklice be shared between two different people?

The Sklice tube is intended for single use to treat a person for a lice infestation. While the entire household should be checked, the official instructions imply individual treatment with one tube per person or infestation. The entire amount needed for one treatment is intended to cover the scalp and hair of the affected individual, using up to the full tube.

Q: Does the effectiveness of Sklice differ in areas where lice have developed resistance to pyrethroid treatments?

Official information indicates that Sklice operates via a mechanism of action that is distinct from that of traditional insecticidal treatments, such as pyrethroids. Its action targets specific chloride channels in the parasites’ nervous system. This distinction in the site of action means the drug is considered to have activity that may differ from older classes of treatment in areas where resistance has developed.

Q: Why do the product instructions emphasize applying Sklice only to dry hair?

The official product instructions explicitly state that the hair and scalp must be dry before the lotion is applied. This is a required administrative step based on the protocol established in the clinical trials that supported the drug's regulatory effectiveness. The instruction is an essential step required for the product to be used as intended.

Q: Is it true that finding nits on the hair after treatment means Sklice did not work?

Official information indicates this is not necessarily the case. Efficacy for Sklice is defined by the proportion of subjects who are free of live lice after treatment. Finding nits after treatment does not automatically indicate failure, as the presence of dead nits is consistent with successful treatment.

Q: What is the typical time frame when official sources suggest re-treating, if needed?

Sklice is described as a single-use product, and re-treatment is not routinely necessary for the same infestation. If live lice are observed 7 days after the application, the official label advises consultation with a healthcare provider regarding other available treatments. The product should not be used again for the same infestation without professional guidance.

Q: Do I need to wash or dry-clean all bedding, clothing, and towels after using Sklice?

Official labeling advises that Sklice is part of an overall lice management program. As part of this program, the label suggests that users should wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding, and towels that the treated person has been in contact with.

Q: If a person is still feeling an itchy scalp after treatment, does that automatically mean the Sklice failed?

Official information indicates that residual itching does not automatically mean the Sklice treatment has failed. Itching has been observed to continue for a period of time following successful treatment, even after the live parasites have been eliminated. Efficacy is based on the absence of live lice, not the presence of residual symptoms.

Q: How long can adult head lice typically survive away from a human host?

Official regulatory guidance focuses on the fact that lice are primarily spread by head-to-head contact. General information referenced by health authorities indicates that adult lice typically do not survive past one or two days without feeding from a human scalp. This provides context for the environmental cleaning measures suggested in the overall lice management program.

Q: What happens if a child accidentally swallows some of the Sklice lotion?

The product is for topical use only, and the label warns against ingestion. Official instructions indicate that if Sklice is accidentally swallowed, calling a healthcare provider or going to the nearest emergency room right away is the required course of action. This underscores the necessity of strict adult supervision during the application process.

Q: Why do the instructions specify rinsing with only water and waiting 24 hours before shampooing?

The official administration protocol requires rinsing the lotion off completely using water only and waiting a full 24 hours before using regular shampoo. This sequence is a required administrative step based on the protocol established during the clinical trials that demonstrated effectiveness. It is essential to follow this instruction for the product to be used as intended.

How should Sklice be stored and disposed of?

Storage and Disposal Requirements for Sklice Lotion

Sklice (ivermectin) lotion must be stored at controlled room temperature, specifically between 20 C to 25 C (68 F to 77 F). Temporary temperature excursions between 15 C and 30 C (59 F and 86 F) are permitted. The product must be strictly kept from freezing.

Handling and Protection

The lotion must be stored out of the reach of children and retained in its original carton.

Disposal

As Sklice is supplied in a single-use tube, regulatory instructions require the user to discard the tube and any remaining lotion immediately after use. Disposal of the tube and remnants should follow standard local procedures. This discarding process is part of the comprehensive lice management program.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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