PCA SKIN INTENSIVE PIGMENT ERASER- pyrithione zinc gel 
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 Intensive Pigment Eraser

Active Ingredient

Pyrithione Zinc 2%

Purpose: Skin Lightener

Indications

For gradual fading of discolorations of th eskin such as freckels, age and liver spots, pigment in the skin that may occur from pregnancy of the use of oral contraceptives.

Warnings

For External use only.

When using this product

  • Avoid contact with the eyes.
  • Some users of this product may experience a mild skin irritation.
  • Do not use on children under 12 years of age unless directed by a physician

Stop use and consult a physician

If skin irritation becomes severe.

Keep out of reach of children.

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

Directions

Adults:  Apply a small amount as a thin layer on the affected area twice daily or use as directed by a physician.

  • If no imporvement is seen after 3 months of treatment, use of this product should be discontinued.
  • Lightening effect of this product may not be noticeable when used on very dark skin.
  • Sun exposure should be limited by using a sunscreen agent or protective clothing when using or after using this product in order to prevent darkening from recurring.

Other Ingredients

Water, PEG-12 Glyceryl Dimyristate, Isododecane, Niacinamide, 1,2 Propanediol, Glycerin, Caprylic/Capric Triglyceride, Tapioca Starch, Polymethylsilsesquioxane, PEG-8, Dimethicone, Panthenol, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Polysilicone-11, Sodium Phytate,
Coco-Caprylate/Caprate, Ammonium Acryloyldimethyltaurate/VP Copolymer,  Hexyl Resorcinol, PEG-23 Glyceryl Distearate, Phenoxyethanol,
Retinol, Tocopheryl Acetate, Polysorbate 20, Sodium Polyacrylate, Butylene Glycol, Bisabolol, Palmeria Palmata Extract, Caprylyl Glycol, Mentha Piperita (Peppermint) Extract, Ceramide NP, Xanthan Gum, Chlorphenesin, Ethylhexyl Stearate, Hydrolyzed Ceratonia Siliqua Seed Extract,
Avena Sativa (Oat) Kernel Extract, Trideceth-6, Decyl Glucoside, Propyl Gallate, Pentylene Glycol, Citrus Grandis (Grapefruit) Peel Oil
Citric Acid

Pigment Eraser

PCA SKIN INTENSIVE PIGMENT ERASER 
pyrithione zinc gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68726-335
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)  
ISODODECANE (UNII: A8289P68Y2)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
PEG-8 GLYCERYL ISOSTEARATE (UNII: 74QQ5X3KL1)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PANTHENOL (UNII: WV9CM0O67Z)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
HEXYLRESORCINOL (UNII: R9QTB5E82N)  
PEG-23 GLYCERYL DISTEARATE (UNII: 527412VE0U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
RETINOL (UNII: G2SH0XKK91)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
Butylene Glycol (UNII: 3XUS85K0RA)  
LEVOMENOL (UNII: 24WE03BX2T)  
DULSE (UNII: 7832HOY4ZQ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
ceramide NP (UNII: 4370DF050B)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
CAROB (UNII: 5MG5Z946UO)  
OAT (UNII: Z6J799EAJK)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68726-335-021 in 1 CARTON07/01/2017
1NDC:68726-335-0114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/01/201705/07/2020
Labeler - PCA Skin (969945133)

Revised: 5/2020
 
PCA Skin