CLEAN AND CLEAR ADVANTAGE 3 IN 1 EXFOLIATING- benzoyl peroxide cream

Clean and Clear Advantage 3 in 1 Exfoliating by

Drug Labeling and Warnings

Clean and Clear Advantage 3 in 1 Exfoliating by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne medication

Use

• For the treatment of acne.

Warnings

For external use only.

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.

Do not use if you

• Have very sensitive skin.
• Are sensitive to benzoyl peroxide.

When using this product

• Avoid unnecessary sun exposure and use sunscreen.
• Avoid contact with the eyes, lips, and mouth.
• Avoid contact with hair and dyed products, which may be bleached by this product.
• Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly 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.

Directions

• Wet face. Gently massage all over face, avoiding eye area. Rinse thoroughly and pat dry.
• Start with one use daily, then gradually increase to two times daily if needed or as directed by a doctor.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of this product and the sunscreen and ask a doctor.

Other Information

• Keep tightly closed
• Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

Water, Cetyl Alcohol, Petrolatum, Steareth-2, Glycerin, Zinc Lactate, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Xanthan Gum, Benzyl Alcohol, Fragrance, Disodium EDTA, Laureth-4, BHT, Menthol

Questions?

877-754-6411; Outside US dial collect 215-273-8755 or visit www.CleanandClear.com

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 141 g Tube Label

Clean
&
Clear®

advantage®
3-in-1
exfoliating
cleanser
5% benzoyl peroxide acne medication

exfoliates skin
treats pimples
helps prevent breakouts

NET WT. 5 OZ. (141g)

INGREDIENTS AND APPEARANCE

CLEAN AND CLEAR ADVANTAGE 3 IN 1 EXFOLIATING 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetyl Alcohol (UNII: 936JST6JCN)
Petrolatum (UNII: 4T6H12BN9U)
Steareth-2 (UNII: V56DFE46J5)
Glycerin (UNII: PDC6A3C0OX)
Zinc Lactate (UNII: 2GXR25858Y)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
High Density Polyethylene (UNII: UG00KM4WR7)
Xanthan Gum (UNII: TTV12P4NEE)
Benzyl Alcohol (UNII: LKG8494WBH)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Laureth-4 (UNII: 6HQ855798J)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Menthol, Unspecified Form (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0211-5	141 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	07/01/2014

Labeler - Johnson & Johnson Consumer Inc. (002347102)