Rx Only

Description

Adazin is a Capsaicin 0.035% and Benzocaine 2% and Lidocaine 2% and Methyl Salicylate 10% Cream is a topical anesthetic and analgesic indicated for the relief of 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.

Active Ingredients

Each gram of Adazin Cream contains:
Capsaicin 0.035% (0.35mg) Topical Analgesic
Benzocaine 2% (20mg) Topical Anesthetic
Lidocaine 2% (20mg) Topical Anesthetic
Methyl Salicylate 10% (100mg) Topical Analgesic

Inactive Ingredients

Water, TEA Salicylate, Glycerin, Dimethyl Isosorbide, Glyceryl Stearate, PEG-100 Stearat, PEG-8, Vanillyl Butyl Ether, Cetyl Alcohol, Glyceryl Stearate, Tridecyl Stearate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Trimellitate, Stearic Acid, Beeswax, Phenoxyethanol, Ethylhexylglycerin, Aloe Vera Gel, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Naproxen, Glucosamine, Sodium Hydroxide, Boswelia Extract, Arnica Oil, MSM, Citric Acid, Lemongrass Oil.

Indications

Anesthetic for relief of 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.

Contraindications

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 use and institute appropriate therapy. Adazin Cream 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 for lidocaine 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 well-controlled 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:

Lidocaine is excreted in human milk. The clinical significance of this observation is unknown. Caution should be exercised when lidocaine is administered to a nursing woman.

PEDIATRIC USE:

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

ADVERSE REACTIONS:

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.

CALL YOUR DOCTOR ABOUT SIDE EFFECTS.

Call your doctor about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

DOSAGE AND ADMINISTRATION:

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

HOW SUPPLIED:

Adazin Cream is supplied as a white cream in:

60 gram tube, NDC 69336-500-02

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on the therapeutic equivalence.

Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86º F). See USP Controlled Room Temperature. Protect from freezing.

Manufactured for:

Sterling-Knight Pharmaceuticals, LLC

Ripley, MS 38663

Item: 50002

Rev. 11/14

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL