PCA GEL- salicylic acid gel

PCA Gel by

Drug Labeling and Warnings

PCA Gel by is a Otc medication manufactured, distributed, or labeled by CP Skin Health Group, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PCA GEL 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-445
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
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)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/01/2020

Labeler - CP Skin Health Group, Inc (611921669)