PCA SKIN Intensive Clarity Treatment

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 Physicians Care Alliance dba PCA Skin. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PCA SKIN INTENSIVE CLARITY TREATMENT- salicylic acid gel 
Physicians Care Alliance dba PCA Skin

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 Intensive Clarity Treatment

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, Sodium Polyacrylate, Glyceryl Stearate, EG-100 Stearate, Polysilicone-11, Bakuchiol, Caprylic/Capric Triglyceride, Maltodextrin, Phenoxyethanol, Coco-Caprylate/Caprate, Retinol, Ethylhexyl Stearate, Ethyl Linoleate, Hexyl Resorcinol, Polysorbate 20, Hexylresorcinol, Dipotassium Glycrrhizinate, Caprylyl Glycol, Xanthan Gum, Chlorphenesin, Trideceth-6,
Pentylene Glycol, Isoamyl Cocoate, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Sodium Citrate, Disodium EDTA, Decyl Glucoside, Myristoyl Nonapeptide-3, Citric Acid

ICTuc

PCA SKIN INTENSIVE CLARITY TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68726-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
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 WHOLE (UNII: U49SHU1VCI)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68726-301-021 in 1 CARTON07/01/2016
1NDC: 68726-301-0129.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/01/201606/30/2019
Labeler - Physicians Care Alliance dba PCA Skin (969945133)

Revised: 6/2019
 
Physicians Care Alliance dba PCA Skin