ZAPZYT ACNE- benzoyl peroxide gel 
Denison Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Zapzyt

Acne Treatement

10% benzoyl peroxide gel

Uses

for the treatement and prevention of acne, pimples, blemishes, blackheads, or whiteheads.

ACTIVE INGREDIENT

Active Ingredient Purpose
Benzoyl Peroxide 10% Acne Treatment

DOSAGE

For best results use up to three times daily. Once your skin has cleared, continue using ZAPZYT to keep new pimples from forming.

DO NOT USE

this product if you have sensitive skin or if you are sensitive to benzoyl peroxide.

When using this product

Avoid unnecessary sun exposure and use sunscreen. Allow ZAPZYT acne gel to dry, then follow the sunscreen directions.

For external use only.

Avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product.

Skin irritation may occur, characterized by redness, burning, itching, peeling or possibily swelling. Mild irritation may be reduced by using this product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still occurs contact a doctor.

Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep away from eyes, lips, and mouth.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Store at room temperature 15° - 30°C (59° - 86°F).

inactive Ingredients

Laureth-4, Carbomer 940, EDTA, Diisopropanolamine, Purified water usp.

USAGE

For the treatment & prevention of acne pimples, blemishes, blackheads or whiteheads.

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ZAPZYT ACNE 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-0010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LAURETH-4 (UNII: 6HQ855798J)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-0010-0628.35 g in 1 TUBE; Type 0: Not a Combination Product12/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2017
Labeler - Denison Pharmaceuticals, Inc. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, Inc.001207208manufacture(0295-0010)

Revised: 12/2018
 
Denison Pharmaceuticals, Inc.