Oil-Free Acne Cleanser (Benzoyl Peroxide) Cream [University Medical Pharmaceuticals Corp] -

OIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]
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NDC	50544-001-06
Set ID	3e284042-8054-47c3-8051-e16782bf6d8c
Category	HUMAN OTC DRUG LABEL
Packager	University Medical Pharmaceuticals Corp
Generic Name
Product Class
Product Number
Application Number	PART333D

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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 every morning and evening. Apply a dime-size amount to damp skin and gently massage, avoiding the eye area. Rinse well. If bothersome peeling occurs, reduce application use. May also be used on chest or back.
INACTIVE INGREDIENT

Inactive ingredients: Water, Disodium Laureth Sulfosuccinate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Glycerin, Cocamidopropyl Betaine, Bakuchiol, Panthenyl Triacetate, Bisabolol, Benzalkonium Chloride, Chamomilla Recuita (Matricaria) Flower Extract, Naringenin, Sea Whip Extract, Polyethylene, Xanthan Gum, Cetyl Alcohol, Magnesium Aluminum Silicate, Sodium Benzoate, Caprylic/Capric Triglyeride, Farnesol, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone.
PRINCIPAL DISPLAY PANEL

AcneFree Clear Skin Treatments

Oil-Free Acne Cleanser
Gentle Exfoliating Microbeads

Advanced Micro-Benzoyl Peroxide

INGREDIENTS AND APPEARANCE

OIL-FREE ACNE CLEANSER
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50544-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzoyl Peroxide (UNII: W9WZN9A0GM) (benzoic acid - UNII:8SKN0B0MIM)	Benzoyl Peroxide	2.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
glycerin (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
LEVOMENOL (UNII: 24WE03BX2T)
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)
CETYL ESTERS WAX (UNII: D072FFP9GU)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50544-001-06	237 g in 1 BOTTLE, PLASTIC

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

Labeler - University Medical Pharmaceuticals Corp (809706252)

Registrant - University Medical Pharmaceuticals Corp (809706252)

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

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