SKINFIX ACNE+ AZELAIC ACID AHA/BHA CLEANSER, 61328-402, DELIST

AZELAIC ACID AHA/BHA CLEANSER by

Drug Labeling and Warnings

AZELAIC ACID AHA/BHA CLEANSER by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AZELAIC ACID AHA/BHA CLEANSER- 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+ AZELAIC ACID AHA/BHA CLEANSER, 61328-402, DELIST

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

• SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME. IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME.

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

AZELAIC ACID AHA/BHA CLEANSER 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-402
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 mL

Inactive Ingredients
Ingredient Name	Strength
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)
TOCOPHEROL (UNII: R0ZB2556P8)
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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-402-15	148 mL in 1 TUBE; Type 0: Not a Combination Product	03/16/2021	10/20/2021
2	NDC: 61328-402-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	03/16/2021	10/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/16/2021	10/20/2021

Labeler - Skinfix, Inc. (203158183)

Revised: 10/2021

Document Id: cecd3ffb-cb8c-7b64-e053-2995a90af77a

34390-5

Set id: 98d1f9a3-938e-40ef-82b4-22f55a055d3e

Version: 7

Effective Time: 20211020