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

Label

ZAPZYT ACNE WASH CLEANSER 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-9055-25177 g in 1 TUBE; Type 0: Not a Combination Product11/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/08/2022
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-9055)

Revised: 11/2022
Document Id: ecf863df-fc0a-4e28-e053-2a95a90a37ce
Set id: ecf863df-fc14-4e28-e053-2a95a90a37ce
Version: 1
Effective Time: 20221108
 
Denison Pharmaceuticals, LLC