GLYTONE ACNE CLEARING CLEANSER- salicylic acid liquid

Glytone Acne Clearing Cleanser by

Drug Labeling and Warnings

Glytone Acne Clearing Cleanser by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA, ACCU BIO-CHEM LABS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Salicylic Acid 2%

Purpose

Acne Treament

Use

• 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

• Dispense a small amount into hand and mix with a little water.
• Apply a thin layer over the entire affected area in a circular motion and rinse thoroughly with warm water two times daily.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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.

Other information

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

Inactive ingredients

WATER, METHYLPROPANEDIOL, POLYACRYLATE CROSSPOLYMER-6, SODIUM LAUROYL SARCOSINATE, HEXYLENE GLYCOL, CAPRYLOYL GLYCINE, CLEOME GYNANDRA LEAF EXTRACT, POTASSIUM SORBATE, PROPANEDIOL, SODIUM BENZOATE, SODIUM HYDROXIDE, XYLITYLGLUCOSIDE.

Principal Display Panel 200mL Bottle

GLYTONE

Acne Clearing Cleanser

2% Salicylic Acid

200 mL/6.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

GLYTONE ACNE CLEARING CLEANSER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
WATER (UNII: 059QF0KO0R)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
CLEOME GYNANDRA LEAF (UNII: 505381240S)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-705-01	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/03/2017

Labeler - Pierre Fabre USA (117196928)

Registrant - Pierre Fabre USA (117196928)

Establishment
Name	Address	ID/FEI	Business Operations
ACCU BIO-CHEM LABS		146789651	analysis(64760-705)