PCA SKIN ACNE- salicylic acid gel

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:    Salicylic Acid (2.0%)     

Purpose:

Acne Treatment

INDICATIONS & USAGE

Uses:

• Clears and reduces the severity of acne blemished
• penetrates pores to help prevent development of new blemishes/blackheads.
  

WARNINGS

Warnings:  For external use only

_____________________________

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

_______________________________

Do not use in or near the eyes

DOSAGE & ADMINISTRATION

Directions:

• Cleanse skin before applying
• Apply a thin layer to affected areas.
• Do not rinse
• Apply once daily.  Gradually increase to twice daily or as directed by a physician.  If excessive dryness or redness occurs, reduce application.
  

INACTIVE INGREDIENT

Inactive Ingredients:

Water/Aqua/Eau, SD Alcohol 40-B, Ethoxydiglycol, Azelaic Acid, Pentylene Glycol, Glycerin, Hydroxyethylcellulose, Butylene Glycol, Potassium Hydroxide, Glycyrrhiza Glabra (Licorice) root extract, Poterium Officinale (Green Burnet) Root, Cinnamomum Cassia Bark, Zingiber Officinale (Ginger) Root.

DESCRIPTION

A gentle and effective 2% salicylic acid acne spot treatment that clears existing acne blemishes while reducing oil production and the occurence of future breakouts

Un traitement doux et effectif a base de 2 % d'acide salicylique pour les boutons d'acne, reduit la production de sebum et la fromation de futures lesions.

HOW SUPPLIED

pcaskin.com    please recycle

2008 Physicians Care Alliance, LLC

Scottsdale, AZ  85253  Made in U.S.A

#21175

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PCA SKIN ACNE  
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
AZELAIC ACID (UNII: F2VW3D43YT)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GINGER (UNII: C5529G5JPQ)
LICORICE (UNII: 61ZBX54883)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CHINESE CINNAMON (UNII: WS4CQ062KM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68726-068-02	7.4 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2004
2	NDC: 68726-068-03	1 in 1 CARTON	05/01/2004
2	NDC: 68726-068-01	29.5 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/01/2004

Labeler - Physicians Care Alliance dba PCA Skin (969945133)