PCA SKIN BPO CLEANSER- benzoyl peroxide gel 
CP Skin Health Group, Inc.

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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pHaze 31 BPO Cleanser

Active Ingredient:       Benzoyl Peroxide (5.0%)   

Purpose: Acne Cleanser

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

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

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For external use only.

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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.

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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.

Directions:

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.

BPO Cleanser

PCA SKIN BPO CLEANSER 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68726-168
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68726-168-041 in 1 CARTON04/01/2010
1NDC:68726-168-01206.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68726-168-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/201001/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00604/01/2010
Labeler - CP Skin Health Group, Inc. (611921669)

Revised: 11/2022
Document Id: ec94d19c-33dc-dc02-e053-2995a90a01be
Set id: eb55cc26-cf47-4e9e-b7a8-23ef82aecce2
Version: 26
Effective Time: 20221103
 
CP Skin Health Group, Inc.