ACNE SPOT TREATMENT 2% BHA- salicylic acid cream

ACNE SPOT TREATMENT by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE SPOT TREATMENT  2% BHA
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-404
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)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
AZELAIC ACID (UNII: F2VW3D43YT)
PROPANEDIOL (UNII: 5965N8W85T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
KAOLIN (UNII: 24H4NWX5CO)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
BENTONITE (UNII: A3N5ZCN45C)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
POLYDEXTROSE (UNII: VH2XOU12IE)
ICODEXTRIN (UNII: 2NX48Z0A9G)
AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777)
COCO GLUCOSIDE (UNII: ICS790225B)
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)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-404-05	15 mL in 1 TUBE; Type 0: Not a Combination Product	03/16/2021

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

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Establishment
Name	Address	ID/FEI	Business Operations
SIGAN INDUSTRIES INC		255106239	manufacture(61328-404)