PHARMA CLEAR CLEANSER- salicylic acid gel

PHARMA CLEAR CLEANSER by

Drug Labeling and Warnings

PHARMA CLEAR CLEANSER by is a Otc medication manufactured, distributed, or labeled by PHARMAGEL INTERNATIONAL INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Salicylic Acid 2.0%

PURPOSE

Acne Medication

USES:

Use for treatment of acne and to decrease bacteria on the skin.

WARNINGS

For external use only

When using this product:

avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the 

   skin. If this occurs, only one medication should be used unless directed by a doctor.

Limit use to the face and neck.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS:

Wet area. Dispense product into hands and massage gently onto face and body, avoiding the eye area. Rinse thoroughly with warm water and pat dry. For best results, use twice daily.

INACTIVE INGREDIENTS:

WATER (AQUA), SODIUM C14-16 OLEFIN SULFONATE, ACRYLATES COPOLYMER, COCAMIDOPROPYL BETAINE, GLYCERIN, CITRIC ACID, DISODIUM EDTA-COPPER, SODIUM HYDROXIDE, TRICLOSAN, PANTHENOL, BISABOLOL, GARCINIA MANGOSTANA (MANGOSTEEN) FRUIT EXTRACT, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHARMA CLEAR CLEANSER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67879-101
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)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRICLOSAN (UNII: 4NM5039Y5X)
PANTHENOL (UNII: WV9CM0O67Z)
LEVOMENOL (UNII: 24WE03BX2T)
GARCINIA MANGOSTANA FRUIT (UNII: 832X5KK78Y)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67879-101-11	175 mL in 1 TUBE; Type 0: Not a Combination Product	06/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/18/2015

Labeler - PHARMAGEL INTERNATIONAL INC (603215182)

Registrant - PHARMAGEL INTERNATIONAL INC (603215182)