ACNEVIR  - sulfur, resorcinol and salicylic acid gel 
Alva-Amco Pharmacal Companies, Inc.

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Drug Facts

Active ingredients

Resorcinol 2x.....................................Acne Treatment
Salicylic Acid 3x.................................Acne Treatment
Sulphur 1x.........................................Acne Treatment

Uses

For the treatment of acne, redness and other eruptions of the skin.

Warnings

For external use only

When using this product

• avoid contact with the eyes
• using other topical acne medications at the same time or immediately after this product may increase dryness or irritation of the skin.  If this occurs, only one medication should be used unless directed by a doctor.

Stop use and ask a doctor if excessive skin irritation occurs or increases.

Keep out of reach of children.  If swallowed, get medical help or contact a poison control center right away.

Directions

• Read all package directions and warnings before use.
• Use only as directed.
• Cleanse skin thoroughly before applying medication.
• Cover the entire affected area with a thin layer one to three time daily.
• Massage gently until absorbed into the skin.
• Intended for use by normally healthy adults only.
• Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor and when using, apply a small amount to a small test patch of affected skin to determine that the medication is well tolerated prior to broader application.

Other information

Serious side effects associated with the use of this product may be reported to the phone number provided below.

Inactive ingredients

Acrylates, aloe barbadensis leaf juice, diazolidinyl urea, lactose, methylparaben, propylene glycol, propylparaben, tetrasodium EDTA, triethanolamine, water.

Questions? 1-800-792-2582

ACNEVIR  sulphur, resorcinol, salicylic acid   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 52389-608 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfur (sulfur) Sulfur 1 [hp_X]  in 1 g Resorcinol (resorcinol) Resorcinol 2 [hp_X]  in 1 g Salicylic acid (Salicylic acid) Salicylic acid 3 [hp_X]  in 1 g

Inactive Ingredients Ingredient Name Strength Aloe vera leaf   Carbomer 934   Diazolidinylurea   Propylene Glycol   Methylparaben   Propylparaben   Edetate sodium   Trolamine   Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52389-608-21 1 TUBE In 1 CARTON contains a TUBE (52389-608-01) 1 52389-608-01 21.25 g In 1 TUBE This package is contained within the CARTON (52389-608-21)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2009

Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Establishment
Name	Address	ID/FEI	Operations
Denison Pharmaceuticals		001207208	manufacture

Revised: 02/2010Alva-Amco Pharmacal Companies, Inc.