OIL FREE ACNE SCRUB SALICYLIC ACID ACNE TREATMENT- salicylic acid liquid

Oil Free Acne Scrub by

Drug Labeling and Warnings

Oil Free Acne Scrub by is a Otc medication manufactured, distributed, or labeled by Apex International Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts
Active Ingredient   Salicylic Acid 2%
Purpose  Acne Treatment

Use for the treatment of acne

WARNINGS

Warnings

For external use only

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product.  This may increase dryness or irritation of the skin.  If this occurs, only one medication should be used unless directed by a doctor.

When using this product avoid contact with eyes.  If contact occurs, flush thoroughly with water.

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

INFORMATION FOR PATIENTS

Directions   Cleanse twice a day.  Wet face.  Apply to hands, add water and work into a lather.  Massage face gently.  Rinse thoroughly.

INACTIVE INGREDIENT

Inactive Ingredients  Water, Glycerin, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Polyethylene, Acrylates Copolymer, Vistis Vinifera (Grape) Seed Extract, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Citrus Grandis (Grapefruit) Fruit Extract, Polyquaternium-7, Camellia Sinensis Leaf Extract, Ascorbyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Anthemis Nobilis Flower Extract, Benzalkonium Chloride, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, PEG-12 Methyl Glucose Dioleate, Sodium Citrate, Disodium EDTA, Agar, Mica, Titanium Dioxide, Sodium Hydroxide, Red 30 Lake, Red 40, Ext. Violet 2, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OIL FREE ACNE SCRUB  SALICYLIC ACID ACNE TREATMENT
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57501-953
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2.5 g  in 125 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Ethylene (UNII: 91GW059KN7)
Acrylic Acid (UNII: J94PBK7X8S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57501-953-04	125 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/08/2010

Labeler - Apex International Mfg (015226132)

Registrant - Apex International Mfg (015226132)

Establishment
Name	Address	ID/FEI	Business Operations
Apex International Mfg		015226132	manufacture