ZAPZYT ACNE WASH CLEANSER- salicylic acid gel
Denison Pharmaceuticals, LLC

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.

----------

Zapzyt Acne Wash Cleanser

For the treatment of acne

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.

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

PRINCIPAL DISPLAY PANEL

label

ZAPZYT ACNE WASH CLEANSER
salicylic acid gel

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

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

#	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	11/03/2022

Labeler - Denison Pharmaceuticals, LLC (001207208)

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

Revised: 11/2022

Document Id: ec940c08-52ea-5812-e053-2995a90a932c

Set id: 80c4ce3a-65d7-e881-e053-2991aa0a0dc0

Version: 2

Effective Time: 20221103

Denison Pharmaceuticals, LLC