ZAPZYT ACNE WASH CLEANSER- salicylic acid gel

Zapzyt Acne Wash Cleanser by

Drug Labeling and Warnings

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

Drug Details [pdf]

PURPOSE

For the treatment of acne

ACTIVE INGREDIENT

Salicylic Acid 2%

Uses

For the treatment of acne

Warnings

For external use only.

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

Directions

• Use daily
• Add water
• Apply to hands
• Massage gently to the affected area
• Rinse thoroughly

Other information

• Store at room temperature 15 0 - 30 0 C (59 0 - 86 0 F)

Inactive ingredients

Purified water, Disodium EDTA, Chamomile Extract, Aloe Vera Gel, Bioterge AS-40, Cocamidopropyl Betaine, Glucamate DOE-120, Glydant, Sodium Chloride

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZAPZYT ACNE WASH CLEANSER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-0071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CHAMOMILE (UNII: FGL3685T2X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-0071-25	141 g in 1 TUBE; Type 0: Not a Combination Product	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/31/2019

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-0071)