Adazin

Name: 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.

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.

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.

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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