GLYTONE ACNE SPOT TREATMENT- sulfur, resorcinol lotion 
Pierre Fabre USA

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GLYTONE Acne Tinted Spot Treatment

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 AcneTinted

GLYTONE ACNE SPOT TREATMENT 
sulfur, resorcinol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-708
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL20 mg  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
WATER (UNII: 059QF0KO0R)  
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)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-708-021 in 1 CARTON10/11/2017
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00610/11/201705/04/2023
Labeler - Pierre Fabre USA (117196928)
Registrant - Pierre Fabre USA (117196928)

Revised: 1/2024
Document Id: 0f3b2665-0860-6c64-e063-6394a90ad311
Set id: 99b23ef3-5b16-4364-9ff7-4b236978e048
Version: 10
Effective Time: 20240118
 
Pierre Fabre USA