PCA SKIN BPO CLEANSER- benzoyl peroxide gel

PCA SKIN BPO Cleanser by

Drug Labeling and Warnings

PCA SKIN BPO Cleanser 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

Active Ingredient:       Benzoyl Peroxide (5.0%)   

Purpose: Acne Cleanser

INDICATIONS & USAGE

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

WARNINGS

Warnings: When using this product,avoid unnecessary sun exposure and use a sunscreen.

____________________________________________________________________________

For external use only.

____________________________________________________________________________

Using other topical acne drugs at the same time or immediately following the sue of this product may increase dryness or irritation of the skin.  If this occurs, only one drug should be sued unless directed by a physician.

_________________________________________________________________________________________

Do not use in or near the eyes.

Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions:

• Apply a small amount of cleanser to damp skin with fingertips and massage into a light foaming lather.
• Wash in a gentle circular motion.
• Rinse with warm (not hot) water and pat dry.
• Start with one treatment daily or as directed by a physician.
  

INACTIVE INGREDIENT

Inactive Ingredients: Water/Aqua/Eau, Gluconolactone, Sodium C14-16 Olefin Sulfonate, Aminomethyl Propanol, Glycerin, Cocamidopropyl Betaine, Aloe Babadensis Leaf Juice, Sodium PCA, Tocopheryl Acetate,  Allantoin, Panthenol, Phytic Acid, Triticum Vulgare (Wheat) Germ Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Anthemis Nobilis Flower Extract, Vitis Vinifera (Grape) Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Arnica Montana Flower Extract, Algae Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate-13, Caprylyl Glycol, Polisobutene, Ehtylhexylglycerin, Hexylene Glycol, Polysorbate 20, Butylene Glycol, Phenoxyethanol, Citrus Grandis (Grapefruit) Peel Oil.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PCA SKIN BPO CLEANSER 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-168
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ARNICA MONTANA (UNII: O80TY208ZW)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
CUCUMBER (UNII: YY7C30VXJT)
GRAPE (UNII: 6X543N684K)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
WHEAT GERM (UNII: YR3G369F5A)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
FYTIC ACID (UNII: 7IGF0S7R8I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68726-168-04	1 in 1 CARTON	04/01/2010
1	NDC: 68726-168-01	206.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68726-168-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/01/2010

Labeler - Physicians Care Alliance DBA PCA SKIN (969945133)