AF FOAM CLEAR SKIN ACNE PORE CLEANSER- benzoyl peroxide aerosol, foam

AF Foam Clear Skin Acne Pore Cleanser by

Drug Labeling and Warnings

AF Foam Clear Skin Acne Pore Cleanser by is a Otc medication manufactured, distributed, or labeled by University Medical Pharmaceuticals Corp, Universal Packaging Systems, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Benzoyl Peroxide 2.5% 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 are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use: If you are using other topical acne drugs at the same time or right before use of this product. This may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.

WHEN USING

When using this product:

• Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
•  Avoid unnecessary sun exposure and use a sunscreen.
  
• Avoid product with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.
  

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 3-in-1 Acne Night Repair.
• Moisten skin.
• Shake well before each use.
• Hold Can upright and press down firmly on dispenser. Apply a small amount of foam (not more than a dollop the size of a gold ball) into hand.
• Using fingers, apply to face and gently massage to cleanse.
• Rinse thoroughly with warn water and pat dry.
• If bothersome peeling occurs, reduce application use.
• If going outside, use a sunscreen.
  

INACTIVE INGREDIENT

Inactive ingredients: Benzylkonium Chloride, Caprylic/Capric Triglyceride, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Decyl Glucoside, Disodium Laureth Sulfosuccinate, Ethylhexylglycerin, Glycerin,  Glyceryl Sterate, Isobutane, Magnesium Aluminum Silicate, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Polyethylene, Propane, Sea Whip Extract, Sodium Benzoate, Sodium Polyacrylate, Stearic Acid, Water, Xanthan Gum.

STORAGE AND HANDLING

Other Information

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

PRINCIPAL DISPLAY PANEL

AcneFree Clear Skin treatments

Oil-Free Acne Pore Cleanser
Micro-Benzoyl Peroxide 2.5%

Rinse-Off Foam
Medicine Stays in Pores Even After Rinsing

INGREDIENTS AND APPEARANCE

AF FOAM CLEAR SKIN ACNE PORE CLEANSER 
benzoyl peroxide aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50544-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
glycerin (UNII: PDC6A3C0OX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
propane (UNII: T75W9911L6)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL ALCOHOL (UNII: 936JST6JCN)
isobutane (UNII: BXR49TP611)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50544-301-40	85 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/01/2011

Labeler - University Medical Pharmaceuticals Corp (809706252)

Registrant - University Medical Pharmaceuticals Corp (809706252)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, INC		177711082	manufacture