GLYTONE ACNE BPO CLEARING CLEANSER- benzoyl peroxide lotion

GLYTONE Acne BPO Clearing Cleanser by

Drug Labeling and Warnings

GLYTONE Acne BPO Clearing Cleanser by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Benzoyl Peroxide 4.5%

Purpose

Acne Treatment

Use

For the treatment of acne.

Warnings

For external use only.

Do not use if you

• have a 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 irritation becomes severe.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

• Dispense a small amount into hand and mix with a little water.
• Apply a thin layer over entire affected area in a circular motion, rinse thoroughly with warm water two times daily.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce 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.

Other information

Store at room temperature 68-77 o F (25-25 o C). Protect this product from excessive heat and direct sun.

Inactive ingredients

WATER, COCAMIDOPROPYL BETAINE, SODIUM C14-16 OLEFIN SULFONATE, HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE, DIPROPYLENE GLYCOL, 1,3-BUTYLENE GLYCOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, XANTHAN GUM, EUPHORBIA CERIFERA (CANDELILLA) WAX, HYDROXYPROPYL METHYLCELLULOSE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, PEG-11 AVOCADO GLYCERIDES

Principal Display Panel - 200 ml Bottle

GLYTONE

Acne BPO Clearing

Cleanser

4.5

Encapsulated Benzoyl Peroxide

200 mL / 6.7 FL. OZ.

INGREDIENTS AND APPEARANCE

GLYTONE ACNE BPO CLEARING CLEANSER 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-712
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
XANTHAN GUM (UNII: TTV12P4NEE)
CANDELILLA WAX (UNII: WL0328HX19)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PEG-11 AVOCADO GLYCERIDES (UNII: YLY4A64409)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-712-01	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/01/2017

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)