ACNEFREE CLEAR SKIN TREATMENTS ADVANCED DEEP CLEANSING DUO- benzoyl peroxide kit

AcneFree Clear Skin Treatments by

Drug Labeling and Warnings

AcneFree Clear Skin Treatments by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Universal Packaging Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzoyl Peroxide 2.5% w/v

Purpose

Acne treatment

Use

for the treatment of acne.

Warnings

For external use only.

Do not use

• if you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation.

Ask a doctor or pharmacist before use

• if you are using other topical acne drugs at the same time or right after 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 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 contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Stop use and ask a doctor if excessive irritation occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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 ingredients

Water, Glycerin, Propylene Glycol, Cocamidopropyl Hydroxysultaine, Sodium C14-16 Olefin Sulfonate, Xanthan Gum, Citric Acid, Potassium Hydroxide, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sodium Lauroyl Lactylate, Glycolic Acid, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Carbomer, Ceramide EOP

Questions/Comments

1-800-321-4576

Preparing the Advanced Cleansing Brush for Use

Installing brush head: Press the brush head onto unit until it locks into position with a click.

Installing batteries: Remove battery cover. Insert 2 AA batteries, aligning +/- symbols. Replace batteries as needed. Do not mix old and new batteries as unit may become damaged.

Directions

Use once a day. Dampen skin, rinse brush head and pat dry to remove excess water before attaching to brush unit. Apply any AcneFree cleanser to brush head, spreading a dime-size amount evenly over brush surface; this will avoid product from splattering onto clothing while brush is in motion. (Cleansers with Benzoyl Peroxide may bleach clothing/towels.) Gently massage over face for approximately 60 seconds, concentrating on troubled areas. Avoid the eye and mouth area. Be careful not to press too hard; this will limit the motion of the brush and reduce its effectiveness. Rinse face, remove brush head, and rinse thoroughly. Recommended: For sensitive skin, use 2-3 times a week on low speed. If any slight redness occurs after use, it should fade within half an hour.

How to Care for Your Advanced Cleansing Brush

To keep your Advanced Cleansing Brush in good condition, do not use abrasive cleansers or chemicals to clean any part of the brush. Do not put any part of the Advanced Cleansing Brush unit in a dishwasher. Do not submerge the Advanced Cleansing Brush in water.

For best results: After use, remove the brush head from handle and rinse with warm soapy water to remove any residue.

Warnings

Avoid direct contact with eyes and hairline/hair. If skin irritation or redness occurs, reduce frequency of use. As this product increases exfoliation of the skin, it may also increase your skin’s sensitivity to the sun. Keep out of reach of children.

PRINCIPAL DISPLAY PANEL – AcneFree Advanced Deep Cleansing Duo

AcneFree®

CLEAR SKIN TREATMENTS

CLEANS 15X BETTER*

Advanced

Deep Cleansing Duo

2-SPEED FACIAL CLEANSING BRUSH + OIL-FREE PURIFYING CLEANSER

• Gently Deep-Cleans Pores
• Clears Blackheads + Breakouts
• Ultra-Soft Bristles
• Waterproof

CONTAINS: 1 CLEANSING BRUSH, 2 BRUSH HEADS, 2 AA BATTERIES, CLEANSER 4 FL. OZ. (118 mL)

*then leading cleanser alone

INGREDIENTS AND APPEARANCE

ACNEFREE CLEAR SKIN TREATMENTS  ADVANCED DEEP CLEANSING DUO
benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-5012

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-5012-02	1 in 1 CARTON; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL

Part 1 of 1

ACNEFREE CLEAR SKIN TREATMENTS 
benzoyl peroxide liquid

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
GLYCOLIC ACID (UNII: 0WT12SX38S)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/25/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/25/2014

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc.		790530976	MANUFACTURE(0187-5012)