GLYTONE Acne Treatment 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]

GLYTONE ACNE TREATMENT- salicylic acid lotion 
Pierre Fabre USA Inc.

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GLYTONE Acne Treatment Lotion

Drug Facts

Purpose

Acne Treatment

Active Ingredient

Salicyclic Acid 1%

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.

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

Stop use and ask a doctor if rash occurs

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.

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 (22-25 C).

Inactive Ingredients

WATER (AQUA), C12-15 ALKYL BENZOATE, PROPANEDIOL, BUTYLENE GLYCOL, C13-15 ALKANE, DIMETHYL ISOSORBIDE, CETEARYL ALCOHOL, BEHENYL ALCOHOL, POLYACRYLATE-13, GLYCERYL STEARATE, ARACHIDYL ALCOHOL, BAKUCHIOL, BISABOLOL, PHENOXYETHANOL, CETEARYL GLUCOSIDE, POLYISOBUTENE, XANTHAN GUM, AMINOMETHYL PROPANOL, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, DISODIUM EDTA, ARACHIDYL GLUCOSIDE, CARNOSINE, POLYSORBATE 20, SORBITAN ISOSTEARATE, GLUCOSE, ARCTIUM LAPPA ROOT EXTRACT

Principal Display Panel - 60 mL

GLYTONE

Acne Treatment Lotion

Acne Therapy

1% Salicylic Acid Bakuchiol

Non-Irritating Formula

60 mL / 2 FL. OZ.

GLYTONE ACNE TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-731
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DOCOSANOL (UNII: 9G1OE216XY)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
XANTHAN GUM (UNII: TTV12P4NEE)
CARNOSINE (UNII: 8HO6PVN24W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C13-15 ALKANE (UNII: 114P5I43UJ)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
BAKUCHIOL (UNII: OT12HJU3AR)
WATER (UNII: 059QF0KO0R)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-731-01	1 in 1 CARTON	09/01/2021
1		1 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 Drug	M006	09/01/2021	01/30/2024

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)

Revised: 1/2024

Document Id: 0f5112f9-2fd3-626e-e063-6394a90a98f9

34390-5

Set id: c972b44c-d932-8428-e053-2995a90a026a

Version: 3

Effective Time: 20240119