PCA SKIN INTENSIVE PIGMENT ERASER- pyrithione zinc gel

PCA Skin Intensive Pigment Eraser by

Drug Labeling and Warnings

PCA Skin Intensive Pigment Eraser by is a Otc medication manufactured, distributed, or labeled by PCA Skin. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PCA SKIN INTENSIVE PIGMENT ERASER 
pyrithione zinc gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-335
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68726-335-02	1 in 1 CARTON	07/01/2017
1	NDC: 68726-335-01	14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/01/2017

Labeler - PCA Skin (969945133)