LidaMantle

LidaMantle® Cream

1 oz. (28.35 g) tube NDC 10337-700-52
3 oz. (85 g) tube NDC 10337-700-19

LidaMantle® Lotion

177 mL bottle NDC 10337-705-10

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature 15°-30° C (59°-86° F).

Protect from freezing.

Mfd. for: Doak Dermatologics, A Subsidiary Of Bradley Pharmaceuticals, Inc., 383 Route 46 West Fairfield, NJ 07004-2402 USA. Mfd. by: Groupe Parima, Inc. Montreal, QC H4S 1X6 Canada. Revised -0305

Pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures, and similar conditions of the skin and mucous membranes.

Apply a thin film to the affected area two or three times daily or as directed by a physician.

Traumatized mucosa, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

WARNINGS

For external use only. Not for ophthalmic use.

PRECAUTIONS

If irritation or sensitivity occurs, or infection appears, discontinue treatment and institute appropriate therapy. LidaMantle® should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.

Carcinogenesis, mutagenesis, and impairment Of fertility

Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.

Use In Pregnancy

Teratogenic Effects: Pregnancy Category B Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and wellcontrolled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.

Pediatric Use

Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.

SIDE EFFECTS

During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.

DRUG INTERACTIONS

No information provided.

During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.

No information provided.