ACNEFREE DERMATOLOGY INSPIRED CARE OIL FREE DEEP CLEANSING DUO- benzoyl peroxide kit

AcneFree Dermatology Inspired Care Oil Free Deep Cleansing Duo by

Drug Labeling and Warnings

AcneFree Dermatology Inspired Care Oil Free Deep Cleansing Duo by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Universal Packaging Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzoyl peroxide 2.5%

Purpose

Acne treatment

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 possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

skin irritation becomes severe

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
• use wash on entire affected area one to two times daily
• because excessive drying of the skin may occur, start with washing once daily, then gradually increase to two times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce cleansing 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.
• may 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 or comments?

1-888-768-2913

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.

Brush Directions

Use Advanced Cleansing Brush 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. 

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. Do not use in shower. After use, remove the brush head from handle and rinse with warm soapy water to remove any residue.

Warnings

Avoid direct contact with eyes, lips, mouth and hairline/hair. If contact occurs, rinse thoroughly with water. If skin irritation or redness occurs, discontinue use. As this product increases exfoliation of the skin, it may also increase your skin’s sensitivity to the sun. Avoid unnecessary sun exposure  and use sunscreen. Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNEFREE DERMATOLOGY INSPIRED CARE OIL FREE DEEP CLEANSING DUO 
benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-408

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-408-02	1 in 1 CARTON; Type 0: Not a Combination Product	08/16/2017

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

Part 1 of 1

ACNEFREE OIL FREE ACNE CLEANSER 
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	08/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/16/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc.		790530976	MANUFACTURE(49967-408)