ACNE CLEANSER- benzoyl peroxide cream

Acne Cleanser by

Drug Labeling and Warnings

Acne Cleanser by is a Otc medication manufactured, distributed, or labeled by Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active  ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do not use

if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

When using this product 

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips and mouth
• avoid contact with hair and dyed fabrics, which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling or possible swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration

Stop use and ask a doctor if

irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.  Avoid contact with eyes.  If contact occurs, flush thoroughly with water.

Directions

• wet face. Gently massage all over face for 20-30 seconds avoiding the eyes.   Rinse thoroughly and pat dry.
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day
• if going outside, apply sunscreen after using this product.  If irritation or sensitivity develops stop use of both products and ask a doctor
• Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas, during the first 3 days.  If no discomfort occurs, follow the directions stated above.

Other information

• keep tightly closed
• store at room temperature (59⁰-77⁰F)

Inactive ingredients

water, cetyl alcohol, petrolatum, acrylates/C10-30 alkyl acrylate crosspolymer, zinc lactate, steareth-2, glycerin, potassium cetyl phosphate, xanthan gum, benzyl alcohol, fragrance, disodium EDTA, laureth-4, BHT, sodium hydroxide, lactic acid, menthol

PRINCIPAL DISPLAY PANEL

mountain falls

Compare to Clean & Clear

fights breakouts even after you wash

10% benzoyl peroxide acne medication

daily acne control cleanser

acne medication

NET WT 5 OZ (141 g)

INGREDIENTS AND APPEARANCE

ACNE CLEANSER 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0264
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	104 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PETROLATUM (UNII: 4T6H12BN9U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ZINC LACTATE (UNII: 2GXR25858Y)
STEARETH-2 (UNII: V56DFE46J5)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LAURETH-4 (UNII: 6HQ855798J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LACTIC ACID (UNII: 33X04XA5AT)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0264-28	141 g in 1 TUBE; Type 0: Not a Combination Product	02/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/18/2014

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(0869-0264)