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Adazin

Generic Name: capsaicin, benzocaine, lidocaine, methyl salicylate
Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Adazin

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

Adazin 
capsaicin/benzocaine/lidocaine/methyl salicylate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69336-500
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.035 g  in 100 g
BENZOCAINE (BENZOCAINE) BENZOCAINE 2 g  in 100 g
LIDOCAINE (LIDOCAINE) LIDOCAINE 2 g  in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 1.0 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
TROLAMINE SALICYLATE  
GLYCERIN  
DIMETHYL ISOSORBIDE  
PEG-100 STEARATE  
PEG-8 STEARATE  
VANILLYL BUTYL ETHER  
CETYL ALCOHOL  
GLYCERYL STEARATE SE  
TRIDECYL STEARATE  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE  
TRIDECYL TRIMELLITATE  
STEARIC ACID  
WHITE WAX  
PHENOXYETHANOL  
ETHYLHEXYLGLYCERIN  
ALOE VERA WHOLE  
(C10-C30)ALKYL METHACRYLATE ESTER  
ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER  
NAPROXEN  
GLUCOSAMINE  
SODIUM HYDROXIDE  
BOSWELLIA SERRATA WHOLE  
ARNICA MONTANA FLOWER  
MONOSODIUM METHYLARSONATE  
CITRIC ACID MONOHYDRATE  
EAST INDIAN LEMONGRASS OIL  
Product Characteristics
Color white Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:69336-500-02 60 g in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/03/2014
Labeler - Sterling Knight Pharmaceuticals, LLC (079556942)
Revised: 12/2014
 
Sterling Knight Pharmaceuticals, LLC



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