PCA Acne

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 5g in 100g
Labeler: Northwest Cosmetic Laboratories
NDC Code: 62282-169

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.

ACTIVE INGREDIENT:                  PURPOSE:

Benzoyl Peroxide (5.0%)                        Acne Treatment

USES:
  • Treats existing and helps prevent new acne blemishes/blackheads.


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 use of this product may increase dryness or irritation of the skin.  If this occurs, only one drug should be used 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 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.

Active Ingredient:

Benzoyl Peroxide (5%)

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
creme pour / acne'

PCA skin

net wt .5 oz/14g
PCA ACNE 
benzoyl perozide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62282-169
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
GLYCERIN 
ALLANTOIN 
PANTHENOL 
PHENOXYETHANOL 
HEXYLENE GLYCOL 
CAPRYLYL GLYCOL 
POLYSORBATE 20 
BUTYLENE GLYCOL 
GLUCONOLACTONE 
CETYL ALCOHOL 
GRAPE 
AMINOMETHYLPROPANOL 
LACTIC ACID 
GRAPEFRUIT SEED 
TEA TREE OIL 
CHAMAEMELUM NOBILE FLOWER 
GLYCERYL MONOSTEARATE 
POLYOXYL 100 STEARATE 
DIMETHICONE 
CYCLOMETHICONE 5 
ASCORBIC ACID 
.ALPHA.-TOCOPHEROL ACETATE, D- 
VITAMIN A PALMITATE 
POTASSIUM CETYL PHOSPHATE 
ETHYLHEXYLGLYCERIN 
Packaging
#Item CodePackage Description
1NDC:62282-169-0114 g in 1 JAR
2NDC:62282-169-027 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33304/01/2010
Labeler - Northwest Cosmetic Laboratories (929572014)

Revised: 06/2010
 
Northwest Cosmetic Laboratories

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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