GLYTONE ACNE TREATMENT MASK- sulfur cream

Glytone Acne Clarifying Treatment Mask by

Drug Labeling and Warnings

Glytone Acne Clarifying Treatment Mask 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 ingredient

Sulfur 6.4%

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

Flammable: Keep away from fire or flame.

Do not use on

• broken skin
• large areas of the skin

When using this product

• apply only to areas with acne
• 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, flush thoroughly with water.

Stop use and ask a doctor

• if excessive skin irritation develops or increases.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• Before first use, break the safety seal by twisting the inverted cap over the star-shaped seal.

• Cleanse the skin thoroughly before applying this mask.

• Apply a generous amount to the entire face and neck, or as directed by your physician.

• Avoid eyes, nostrils, and lips.

• Leave on skin for 20-25 minutes.

• Remove with lukewarm water in a gentle circular motion. Pat dry.

• Use one to three times a week, or as directed by your physician.

Other information

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

Inactive Ingredients

WATER, BENTONITE, ISOPROPYL ALCOHOL, KAOLIN, ZINC OXIDE, GLYCERIN, CALCIUM OXIDE, COCAMIDE MIPA, FRAGRANCE, METHYLPARABEN, SODIUM LAURYL SULFATE.

Principal Display Panel - 85 g Carton

GLYTONE

Acne

Treatment

Mask

ACNE THERAPY

6.4% SULFUR

NET WT. 85 g / 3 OZ.

INGREDIENTS AND APPEARANCE

GLYTONE ACNE TREATMENT MASK 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-710
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	64 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENTONITE (UNII: A3N5ZCN45C)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
KAOLIN (UNII: 24H4NWX5CO)
ZINC OXIDE (UNII: SOI2LOH54Z)
GLYCERIN (UNII: PDC6A3C0OX)
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-710-01	1 in 1 CARTON	03/14/2018
1		85 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	03/14/2018

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)