PCA SKIN ACNE- benzoyl perozide cream

PCA SKIN Acne by

Drug Labeling and Warnings

PCA SKIN Acne 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 Treatment

INDICATIONS & USAGE

USES:

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

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 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.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PCA SKIN ACNE 
benzoyl perozide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-169
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 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68726-169-04	1 in 1 CARTON	04/01/2010
1	NDC: 68726-169-01	14 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 68726-169-02	7 g in 1 TUBE; 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)