GLYTONE ACNE BPO TREATMENT GEL- benzoyl peroxide gel

GLYTONE Acne BPO Treatment Gel by

Drug Labeling and Warnings

GLYTONE Acne BPO Treatment Gel 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

Purpose

Acne Treatment

Active Ingredient

Benzoyl Peroxide 5%

Use

For the treatment of Acne.

Dries and clears acne blemishes and allows skin to heal.

Penetrates pores to eliminate most acne blemishes, blackheads and whiteheads.

Helps prevent the development of new acne blemishes, blackheads and whiteheads.

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 eyes. If eye contact occurs, rinse thoroughly with water.

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.

Keep out of reach of children.

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

Directions

Cleanse the skin thoroughly before applying product.

Cover the affected area(s) with a thin layer one to three times daily.

Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily or as directed by your physician.

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 of 68-77 F (22-25 C).

Inactive Ingredients

Water (AQUA), PROPANEDIOL, DIMETHYL ISOSORBIDE, BUTYLENE GLYCOL, GLYCERIN, 1,2-HEXANEDIOL, ACRYLAMIDE/SODIUM ACRYLOYL-DIMETHYLTAURATE COPOLYMER, ISOHEXADECANE, HYDROXYACE-TOPHENONE, POLYSORBATE 80, POLYGLYCERYL-2 ISOSTEARATE, XANTHAN GUM, ENANTIA CHLORANTHA BARK EXTRACT, SODIUM CITRATE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, CITRIC ACID, DIETHYLHEXYL SODIUM SULFOSUCCINATE, CARBOMER, SODIUM HYDROXIDE, ETHYLHEXYL-GLYCERIN, CITRUS GRANDIS (GRAPEFRUIT) SEED EXTRACT, ECHINACEA ANGUSTIFOLIA EXTRACT, DIMETHICONE, ARCTIUM LAPPA ROOT EXTRACT, PHENOXYETHANOL, OLEANOLIC ACID, PEG-40 STEARATE, SILICA, SORBITAN STEARATE, TOCOPHEROL

Principal Display Panel - 60 mL

GLYTONE

Acne BPO Treatment Gel

Acne Therapy

5% Micronized Benzoyl Peroxide

Non-Irritating Formula

60 mL/ 2 FL. OZ.

INGREDIENTS AND APPEARANCE

GLYTONE ACNE BPO TREATMENT GEL 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-732
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

Inactive Ingredients
Ingredient Name	Strength
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-40 STEARATE (UNII: ECU18C66Q7)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TOCOPHEROL (UNII: R0ZB2556P8)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER 1342 (UNII: 809Y72KV36)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-732-01	1 in 1 CARTON	09/01/2021	01/31/2025
1		1 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 Drug	M006	09/01/2021	01/31/2025

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)