GLYTONE ACNE TREATMENT- salicylic acid spray

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 2%

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

Flammable: Keep away from fire or flame

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 use only one topical acne medication at a time.
• avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
• spray in a well ventilated area. Do not inhale.

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

• Spray directly onto cleansed affected areas of the back, shoulders and chest by holding 3 to 6 inches away from the skin one to three times daily.
• Pump works upside down for optimal application.
• Let dry prior to putting on clothes.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Water, Isopropyl Alcohol, Benzalkonium Chloride, Polysorbate 20,

Principal Display Panel - 240 mL Spray Bottle

GLYTONE

Acne

Treatment

Spray (Back & Chest)

ACNE THERAPY

2% Salicylic Acid

240 mL / 8.0 FL. OZ.

Principal Display Panel - 60 mL Spray Bottle

GLYTONE

Acne

Treatment

Spray (Back & Chest)

ACNE THERAPY

2% Salicylic Acid

60 mL / 2 FL. OZ.

INGREDIENTS AND APPEARANCE

GLYTONE ACNE TREATMENT 
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-711
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-711-01	240 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/06/2018
2	NDC: 64760-711-02	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/06/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/06/2018

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)