ZAPZYT ACNE- benzoyl peroxide gel

Zapzyt Acne by

Drug Labeling and Warnings

Zapzyt Acne by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

WARNINGS

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZAPZYT ACNE 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-0010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAURETH-4 (UNII: 6HQ855798J)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-0010-06	28.35 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/01/2017

Labeler - Denison Pharmaceuticals, Inc. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	manufacture(0295-0010)