GLYTONE ACNE FACIAL MASQUE- sulfur cream 
Genesis Pharmaceutical, Inc.

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.

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Glytone Acne Facial Masque

Drug Facts

Active ingredient

Sulfur 6.4%

Purpose

Acne treatment

Use  For the treatment of acne.

  • penetrates pores to control acne blemishes, blackheads, and whiteheads.
  • helps keep skin clear of new acne blemishes, blackheads, and whiteheads.

Warnings

For external use only

Flammable: Keep away from fire or flame

Do not use on

  • broken skin
  • large areas of the skin

When using this product

  • 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.
  • rinse right away with water if it gets in eyes.

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

  • Cleanse the skin thoroughly before applying this masque.
  • Apply a generous amount to entire face and neck, or as directed by a doctor.
  • Avoid eyes, nostrils, and lips. Leave on skin for 20‐25 minutes.
  • Remove with lukewarm water in a gentle circular motion. Pat dry.
  • Use 1‐3 times a week, or as directed by a doctor.

Inactive Ingredients

Bentonite, Isopropyl Alcohol, Kaolin, Zinc Oxide, Water, Glycerin, Calcium Oxide, Sodium Lauryl Sulfate, Cocamide MIPA, Fragrance, Methylparaben

Principal Display Panel - 85 g Carton

GLYTONE

ACNE

treatment

acne facial masque

6.4 SULFUR

NET WT. 85 g / 3 OZ.Glytone Acne Facial Masque 85 g tube carton

GLYTONE ACNE FACIAL MASQUE 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR64 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENTONITE (UNII: A3N5ZCN45C)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
KAOLIN (UNII: 24H4NWX5CO)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-033-021 in 1 CARTON05/12/201408/04/2017
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D05/12/201408/04/2017
Labeler - Genesis Pharmaceutical, Inc. (117196928)

Revised: 8/2016
 
Genesis Pharmaceutical, Inc.