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Glytone Acne Spot Treatment

Medically reviewed on October 18, 2016.

Dosage form: lotion
Ingredients: RESORCINOL 20mg in 1mL, SULFUR 80mg in 1mL
Labeler: Genesis Pharmaceutical, Inc.
NDC Code: 64760-708

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

GLYTONE Acne Tinted Spot Treatment

Drug Facts

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

Flammable. Keep away from open fire or flame.

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
  • Shake well.
  • 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, Isopropyl Alcohol, Propylene Glycol, Acetone, Titanium Dioxide, Magnesium Aluminum Silicate, Iron Oxides, Octoxynol-9, Xanthan Gum, Fragrance, Chloroxylenol

Principal Display Panel 60 mL Carton

GLYTONE

Acne Tinted

Spot Treatment

2.0 Resorcinol

8.0 Sulfur

60 mL /  2 FL. OZ

Glytone Acne Tinted Spot Treatment

GLYTONE ACNE SPOT TREATMENT 
sulfur, resorcinol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-708
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RESORCINOL (RESORCINOL) RESORCINOL20 mg  in 1 mL
SULFUR (SULFUR) SULFUR80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
ACETONE 
TITANIUM DIOXIDE 
MAGNESIUM ALUMINUM SILICATE 
BROWN IRON OXIDE 
OCTOXYNOL 9 
XANTHAN GUM 
CHLOROXYLENOL 
Packaging
#Item CodePackage Description
1NDC:64760-708-011 BOTTLE, PLASTIC in 1 CARTON
160 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/21/2016
Labeler - Genesis Pharmaceutical, Inc. (117196928)

 
Genesis Pharmaceutical, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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