PCA SKIN ACNE- benzoyl perozide cream 
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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PCA Skin Acne Cream

ACTIVE INGREDIENT:                 Benzoyl Peroxide (5.0%)                      

Purpose: Acne Treatment

USES:


WARNINGS:

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

DIRECTIONS: Cleanse skin thoroughly before applying.  Apply a small amount of cream to areas where pimples occur.  Do not rinse.   Start with one acne treatment every other day and gradually increase to once daily or as directed by a physician. If going outside, use a sunscreen. Allow Acne Cream to dry, then follow sunscreen label directions.  If irritation develops or sensitivity develops, discontinue use of both products and consult a physician.

Other Ingredients: Water/Aqua/Eau, Gluconolactone, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Vitis Vinifera (Grape) Seed Oil, Aminomethyl Propanol, Lactic Acid, Aloe Barbadensis Leaf Juice, Cyclopentasiloxane, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Melaleuca Arternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Anthemis Nobilis Flower Extract, Citrus Grandis (Grapefruit) Peel Oil, Allantoin, Panthenol, Polyacrylate-13, Polyisobutene, Caprylyl Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Potassium Cetyl Phosphate, Ethylhexylglycerin, Hexylene Glycol, Polysorbate 20, Butylene Glycol, Phenoxyethanol.

Acne Cream Ctn

PCA SKIN ACNE 
benzoyl perozide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68726-169
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GRAPE (UNII: 6X543N684K)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
LACTIC ACID (UNII: 33X04XA5AT)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
TEA TREE OIL (UNII: VIF565UC2G)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68726-169-041 in 1 CARTON04/01/2010
1NDC:68726-169-0114 g in 1 JAR; Type 0: Not a Combination Product
2NDC:68726-169-027 g in 1 TUBE; Type 0: Not a Combination Product04/01/201008/31/2021
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: ec945104-25da-3e1f-e053-2a95a90ac559
Set id: 257bd9dd-93f9-4996-8478-8198be3ef683
Version: 20
Effective Time: 20221103
 
CP Skin Health Group, Inc.