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

Acne Treatment Lotion GLYTONE

Acne Treatment Lotion

1.0% Salicylic Acid

NON-IRRITATING FORMULA

NET WT. 56.7 g / 2 OZ.

GLYTONE ACNE TREATMENT
salicylic acid lotion

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M006	10/20/2017	06/16/2024

Labeler - Pierre Fabre USA Inc. (117196928)