PCA GEL- salicylic acid gel
CP Skin Health Group, 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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PCA SKIN Acne Gel Advanced Treatment

Active Ingredients

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

For the treatment of acne
Helps keep skin clear of new acne pimples, blackheads or whiteheads

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 medication at a time.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

Clean the skin thoroughly before applying this product
Cover the entire affected area with a thin layer one to three times daily
because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Alcohol, Butylene Glycol, Cellulose, Denatonium Benzoate, Ethoxydiglycol, Ethyl Linoleate, Hexylresorcinol, Hydroxyethylcellulose, Isopentyldiol, Mandelic Acid, Pentylene Glycol, Polyacrylate Crosspolymer-6, Polyglyceryl-10 Dioleate, Polyglyceryl-10 Dipalmitate, Potassium Hydroxide, Sodium Acetate, t-Butyl Alcohol, Water

acnegel2020

PCA GEL
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68726-445
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
HEXYLRESORCINOL (UNII: R9QTB5E82N)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
MANDELIC ACID (UNII: NH496X0UJX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
POLYGLYCERYL-10 DIPALMITATE (UNII: 84VD0IA2S6)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68726-445-02	1 in 1 CARTON	08/01/2020
1	NDC:68726-445-01	29.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:68726-445-03	7.3 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M006	08/01/2020

Labeler - CP Skin Health Group, Inc (611921669)