Zapzyt Acne Wash Cleanser

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]

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.

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Zapzyt Acne Wash Cleanser

Active Ingredient

Salicylic Acid 2%

Purpose

For the treatment of acne.

Warnings

For external use only.

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

using other topical acne medications 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 physician.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

For the treatment of acne.

Directions

• use twice daily
• apply to hands
• add water
• massage gently to the affected area
• rinse thoroughly

Other information

• Store at room temperature 15º-30ºC (59º-86ºF).

Inactive ingredients

Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, PEG-120 Methyl Glucose Dioleate, Propylene Glycol, Purified Water, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL

ZAPZYT ACNE WASH CLEANSER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9055
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 CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
CHAMOMILE (UNII: FGL3685T2X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9055-25	177 g in 1 TUBE; Type 0: Not a Combination Product	11/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/08/2022

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-9055)

Revised: 11/2022

Document Id: ecf863df-fc0a-4e28-e053-2a95a90a37ce

34390-5

Set id: ecf863df-fc14-4e28-e053-2a95a90a37ce

Version: 1

Effective Time: 20221108