PCA SKIN INTENSIVE CLARITY TREATMENT- salicylic acid gel

PCA SKIN Intensive Clarity Treatment by

Drug Labeling and Warnings

PCA SKIN Intensive Clarity Treatment 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 Ingredient

Salicylic Acid (2.0%)     

Purpose

Acne Treatment

Uses

For the treatment of acne.  Helps keep skin clear of new acne pimples, blackheads and/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 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

• Cleanse 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 daily or every other day.

Inactive Ingredients

Water, Glycerin, PEG-12 Glyceryl Dimyristate, Cyclopentasiloxane, Isododecane, Niacinamide, Butylene Glycol, Dimethicone, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Alcohol, Isoamyl Laurate, Glyceryl Stearate, PEG-100 Stearate, Sodium Polyacrylate,
Polysilicone-11, Bakuchiol, Caprylic/Capric Triglyceride, Maltodextrin, Phenoxyethanol, Coco-Caprylate/Caprate, Hexyl Resorcinol, Ethylhexyl Stearate, Retinol, Ethyl Linoleate, Polysorbate 20, Hexylresorcinol, Dipotassium Glycrrhizinate, Caprylyl Glycol, Trideceth-6, Xanthan Gum, Chlorphenesin, Pentylene Glycol, Isoamyl Cocoate, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Sodium Citrate, Disodium EDTA, Decyl Glucoside, Myristoyl Nonapeptide-3, Citric Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PCA SKIN INTENSIVE CLARITY TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-359
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
BAKUCHIOL (UNII: OT12HJU3AR)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCO-CAPRYLATE (UNII: 4828G836N6)
RETINOL (UNII: G2SH0XKK91)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
HEXYLRESORCINOL (UNII: R9QTB5E82N)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLORPHENESIN (UNII: I670DAL4SZ)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOAMYL COCOATE (UNII: 14OG46E98E)
SYRINGA VULGARIS FLOWER (UNII: 9V5O040S3W)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68726-359-02	1 in 1 CARTON	06/08/2018
1	NDC: 68726-359-01	29.5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68726-359-03	2 g in 1 TUBE; Type 0: Not a Combination Product	06/08/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/08/2018

Labeler - Physicians Care Alliance dba PCA Skin (969945133)