GLYTONE ACNE SPOT TREATMENT- sulfur, resorcinol lotion

Glytone Acne Spot Treatment by

Drug Labeling and Warnings

Glytone Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Resorcinol 2 %

Sulfur 8 %

Purpose

Acne treatment

Uses

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

Do not use on

• broken skin
• large areas of the skin

When using this product

• apply only to areas with acne
• rinse right away with water if it gets in eyes
• 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.

Stop use and ask a doctor

• if skin irritation occurs or gets worse

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 this product.
• Cover the affected area 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 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, PROPYLENE GLYCOL,ALCOHOL DENAT., POLYSORBATE 20,CAPRYLIC/CAPRIC TRIGLYCERIDE,MAGNESIUM ALUMINUM SILICATE,SODIUM STEAROYL GLUTAMATE,CETEARYL ALCOHOL, GLYCERYLSTEARATE, POLYSORBATE 60, CHLOROXYLENOL, ETHYLHEXYLGLYCERIN,FRAGRANCE, PHENOXYETHANOL,POLYGLYCERYL-6 PALMITATE/SUCCINATE,
XANTHAN GUM, IRON OXIDES,TITANIUM DIOXIDE.

Principal Display Panel 30 mL Carton

GLYTONE

Acne Tinted Spot Treatment

2.0 Resorcinol

8.0 Sulfur

30 mL / 1 FL. OZ

INGREDIENTS AND APPEARANCE

GLYTONE ACNE SPOT TREATMENT 
sulfur, resorcinol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-708
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	20 mg  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
XANTHAN GUM (UNII: TTV12P4NEE)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FARNESOL (UNII: EB41QIU6JL)
ALCOHOL (UNII: 3K9958V90M)
POLYGLYCERIN-6 (UNII: M51422LRAM)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-708-02	1 in 1 CARTON	10/11/2017
1		30 mL 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	10/11/2017

Labeler - Pierre Fabre USA (117196928)

Registrant - Pierre Fabre USA (117196928)