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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-0071
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
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-0071-25141 g in 1 TUBE; Type 0: Not a Combination Product01/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/31/201911/03/2022
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-0071)

Revised: 11/2022
 
Denison Pharmaceuticals, LLC