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 - Glytone Acne Treatment Mask Carton

GLYTONE

Acne

Treatment

Mask

ACNE THERAPY

6.4% SULFUR

NET WT. 85 g / 3 OZ.

AcneTreatmentMask

Principal Display Panel - 85 g - Glytone Acne Clarifying Treatment Mask Carton

GLYTONE

ACNE CLARIFYING TREATMENT MASK

ACNE THERAPY

6.4% SULFUR

1% GLYCOLIC ACID

1% LACTIC ACID

NET WT. 85 G / 3 OZ.

Acne Clarifying Treatment Mask

GLYTONE ACNE TREATMENT MASK
sulfur cream

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

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

Ingredient Name	Strength
Inactive Ingredients
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M006	03/14/2018	06/05/2024

GLYTONE ACNE CLARIFYING TREATMENT MASK
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64760-714
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
KAOLIN (UNII: 24H4NWX5CO)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCOLIC ACID (UNII: 0WT12SX38S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LACTIC ACID LACTATE, L- (UNII: 26T86KT372)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
BENTONITE (UNII: A3N5ZCN45C)
GLYCERIN (UNII: PDC6A3C0OX)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BISABOLOL OXIDE A (UNII: 16AE65F94Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM GLUCONATE (UNII: R6Q3791S76)
TROPOLONE (UNII: 7L6DL16P1T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL RICINOLEATE (UNII: ZUE0CEL42O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64760-714-01	1 in 1 CARTON	06/23/2023	10/10/2024
1		85 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	06/23/2023	10/10/2024

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)