GLYTONE ACNE TREATMENT- salicylic acid lotion

Glytone Acne Treatment by

Drug Labeling and Warnings

Glytone Acne Treatment 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

Salicylic Acid 1 %

Purpose

Acne Treatment

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

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.

• avoid contact with the eyes. If eye contact occurs, flush thoroughly with water.

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 medication.
• Cover the affected area(s) with a thin layer one to three times daily, or as directed by your physician.
• 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.

Other Information

 Store at room temperature of 68-77° F (20-25° C).

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Ethoxydiglycol, Propylene Glycol, Glyceryl Laurate, PEG-100 Stearate, Cyclopentasiloxane, Cetearyl Glucoside, Behenyl Alcohol, Bisabolol, Carnosine, Hydrogenated Lecithin, Oryza Sativa (Rice) Bran Extract, Xanthan Gum, Sodium Hydroxide, Polysilicone-11, Disodium EDTA, Methylparaben, Ethylparaben, Butylparaben, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Propylparaben, Isobutylparaben, Phenoxyethanol

Principal Display Panel

​​GLYTONE

Acne Treatment Lotion

1.0% Salicylic Acid

NON-IRRITATING FORMULA

NET WT. 56.7 g / 2 OZ.

INGREDIENTS AND APPEARANCE

GLYTONE ACNE TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-709
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BIS-ETHOXYDIGLYCOL SUCCINATE (UNII: YGQ120RH3I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL LAURATE (UNII: Y98611C087)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNOSINE (UNII: 8HO6PVN24W)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
RICE BRAN (UNII: R60QEP13IC)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ACRYLIC ACID (UNII: J94PBK7X8S)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
PEG-100 STEARATE (UNII: YD01N1999R)
DOCOSANOL (UNII: 9G1OE216XY)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
LEVOMENOL (UNII: 24WE03BX2T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-709-01	1 in 1 CARTON	10/20/2017
1		56.7 g in 1 TUBE; 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	10/20/2017

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)