SKINFIX - ACNE+ 2% BHA SPOT TREATMENT, 61328-401, DELIST

AZELAIC ACID BHA SPOT TREATMENT by

Drug Labeling and Warnings

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

Drug Details [pdf]

AZELAIC ACID BHA SPOT TREATMENT- salicylic acid cream 
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 SPOT TREATMENT, 61328-401, 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

APPLY DIRECTLY ONYO BLEMISH OR AFFECTED AREA AFTER CLEANSING 1-2X DAILY.

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

Inactive Ingredients

WATER (EAU), KAOLIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, AZELAIC ACID, PROPANEDIOL, STEARYL ALCOHOL, POLYGLYCERYL-2 STEARATE, NIACINAMIDE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, GLYCERIN, BENTONITE, TOCOPHEROL, POLYDEXTROSE, DEXTRIN, AMYLOPECTIN, GLYCERYL STEARATE, ZINC PCA, STEARYL GLYCYRRHETINATE, ETHYLHEXYLGLYCERIN, XANTHAN GUM, CITRIC ACID, POTASSIUM CETYL PHOSPHATE, PHENOXYETHANOL, SODIUM HYDROXIDE, POTASSIUM SORBATE, SODIUM BENZOATE

QUESTIONS?

1.866.927.2783

AZELAIC ACID BHA SPOT TREATMENT 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-401
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)
KAOLIN (UNII: 24H4NWX5CO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
AZELAIC ACID (UNII: F2VW3D43YT)
PROPANEDIOL (UNII: 5965N8W85T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
BENTONITE (UNII: A3N5ZCN45C)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYDEXTROSE (UNII: VH2XOU12IE)
ICODEXTRIN (UNII: 2NX48Z0A9G)
AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ZINC PIDOLATE (UNII: C32PQ86DH4)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-401-05	15 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: cecd39c8-6eaa-23aa-e053-2995a90a570a

34390-5

Set id: a96149bd-7d47-4df1-a015-6bde0e39ef8a

Version: 7

Effective Time: 20211020