AF FOAM SENSITIVE ACNE PORE CLEANSER- salicylic acid aerosol, foam

AF Foam Sensitive Acne Pore Cleanser by

Drug Labeling and Warnings

AF Foam Sensitive Acne Pore Cleanser by is a Otc medication manufactured, distributed, or labeled by University Medical Pharmaceuticals Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: Salicylic Acid 1.5% w/v

PURPOSE

Purpose: Acne Treatment

INDICATIONS & USAGE

Use for the treatment of acne.

WARNINGS

Warnings: For external use only

DO NOT USE

Do not use If you have a known allergy to Salicylic Acid or aspirin.
Using other topical acne medications at the same time or right after use of this product may increase drynes or irritation of the skin. If this occurs only one medication should be used unless directed by a doctor.

WHEN USING

When using this product

• Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. If you have aspirin sensitivity, consult a physician prior to use.
  

STOP USE

Stop use and ask a doctor if excessive irritation occurs.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• Use AM and PM. Recommended: after AM use, follow with AcneFree All-Day Acne Control. After PM use, follow with AcneFree 3-in-1 Acne Night Repair.
• Moisten skin.
• Shake can before use.
• Press down firmly on dispenser and apply a small amount of foam (not more than a dollop the size of golf ball) into hand.
• Using fingers, apply to face and gently massage to cleanse.
• Rinse thoroughly with warm water and pat dry.
• If bothersome peeling occurs, reduce application use.
• If going outside, use a sunscreen.

STORAGE AND HANDLING

Other information

• Store at 60o- 85o F (15o-30o C).
• Pressurized container: Protect from sunlight and do not expose to temperatures exceeding 120oF
  (49o C). Do not puncture or burn, even after use. Use only as directed.
  

INACTIVE INGREDIENT

Inactive ingredients: Avena Sativa (Oat) Kernel Extract, Bisabolol, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Glycerin, Methylisothiazolinone, Phenoxyethanol, Sodium Chloride, Sodium Hydroxide, Sodium C14-16 Olefin Sulfonate, Tetrasodium Glutamate Diacetate, Water/Aqua/Eau, Zinc PCA, Zingiber Officinale (Ginger) Root Extact.

PRINCIPAL DISPLAY PANEL

AcneFree Sensitive

Gentle Formula
Acne Pore Cleanser
Salicylic Acid 1.5%

Rinse-Off Foam
Medicine Stays In Pores Even After Rinsing

INGREDIENTS AND APPEARANCE

AF FOAM SENSITIVE ACNE PORE CLEANSER 
salicylic acid aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50544-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ)	salicylic acid	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
oat (UNII: Z6J799EAJK)
LEVOMENOL (UNII: 24WE03BX2T)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
glycerin (UNII: PDC6A3C0OX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
water (UNII: 059QF0KO0R)
ZINC PIDOLATE (UNII: C32PQ86DH4)
ginger (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50544-304-40	85 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/15/2011

Labeler - University Medical Pharmaceuticals Corp (809706252)

Registrant - University Medical Pharmaceuticals Corp (809706252)