BHA CLEANSER 2%- salicylic acid lotion 
Skinfix, Inc.

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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SKINFIX - ACNE+ 2% BHA CLEANSER

Active Ingredient

SALICYLIC ACID 2%

Purpose

ACNE TREATMENT

USES

HELPS CLEAR ACNE BLEMISHES AND ALLOWS SKIN TO HEAL. HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away

Directions

DISPENSE A PEA-SIZED AMOUNT ONTO DAMP PALMS AND WORK INTO A LATHER. MASSAGE OVER FACE AND NECK IN AN OUTWARD, CIRCULAR MOTIONS, CONCENTRATING ON OILY AND BREAKOUT-PRONE AREAS. RINSE THOROUGHLY WITH WARM WATER.

ALLERGY ALERT  DO NOT USE THIS PRODUCT IF YOU HAVE A KNOWN ALLERGY TO SALICYLIC ACID.

Inactive Ingredients

WATER (EAU), COCAMIDOPROPYL HYDROXYSULTAINE, STEARYL ALCOHOL, PROPANEDIOL, DISODIUM COCOYL GLUTAMATE, GLYCOLIC ACID, BENTONITE, NIACINAMIDE, SODIUM HYDROXIDE, AZELAIC ACID, CAMELLIA SINENSIS LEAF EXTRACT, TOCOPHEROL, GLYCERIN, ETHYLHEXYLGLYCERIN, POLYDEXTROSE, DEXTRIN, AMYLOPECTIN, SODIUM COCOYL GLUTAMATE, XANTHAN GUM, SODIUM CHLORIDE, CITRIC ACID, POTASSIUM SORBATE, PHENOXYETHANOL, SODIUM BENZOATE

QUESTIONS?

1.866.927.2783

61328-403-5561328-403-55

BHA CLEANSER  2%
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-403
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PROPANEDIOL (UNII: 5965N8W85T)  
DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
BENTONITE (UNII: A3N5ZCN45C)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
AZELAIC ACID (UNII: F2VW3D43YT)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61328-403-551 in 1 BOX02/04/2022
1NDC:61328-403-15148 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:61328-403-0130 mL in 1 TUBE; Type 0: Not a Combination Product02/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/04/2022
Labeler - Skinfix, Inc. (203158183)
Registrant - Skinfix, Inc. (203158183)
Establishment
NameAddressID/FEIBusiness Operations
SIGAN INDUSTRIES INC255106239manufacture(61328-403)

Revised: 2/2022
Document Id: a798a616-6a75-4693-810b-1115076b75c7
Set id: ceccb599-ff9e-fc87-e053-2a95a90a411a
Version: 3
Effective Time: 20220203
 
Skinfix, Inc.