Zapzyt Acne Wash Cleanser (Salicylic Acid) Gel [Denison Pharmaceuticals, Llc] -

ZAPZYT ACNE WASH CLEANSER (SALICYLIC ACID) GEL [DENISON PHARMACEUTICALS, LLC]
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NDC	0295-0071-25
Set ID	80c4ce3a-65d7-e881-e053-2991aa0a0dc0
Category	HUMAN OTC DRUG LABEL
Packager	Denison Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number	PART333D

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Denison Pharmaceuticals, LLC (001207208)

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

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