GLYTONE ACNE TREATMENT - sulfur cream 
Glytone

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 Treatment



Active ingredients

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.



Inactive ingredients bentonite, calcium oxide, fragrance (Parfum), glycerin, Isopropyl Alcohol, Kaolin, Lauramide DEA, Methylparaben, sodium lauryl sulfate, Water (Aqua), Zinc oxide.



Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.



When using this product

with other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.


avoid contact with eyes. If product gets into the eyes, rinse thoroughly with water. If excessive skin irritation develops or increases, discontinue use and consult a doctor.


When using this product:

with other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Avoid contact with eyes. If product gets into the eyes, rinse thoroughly with water. If excessive skin irritation develops or increases, discontinue use and consult a doctor.

Flammable-keep away from open fire or flame.

Store at room temperature. Keep tightly closed. Masque may contract from sides of jar. This is normal and does not affect quality.



Acne treatment



Cleanse the skin thoroughly before applying medication. 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 ukewarm water in a gentle circular motion. Pat skin dry.

label


Glytone acne

treatment

acne facial masque

6.4% sulfur

50 mle/net wt. 1.7 oz(50g)

GLYTONE ACNE TREATMENT 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64760-210
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sulfur (sulfur) sulfur9 g  in 141 g
Inactive Ingredients
Ingredient NameStrength
Bentonite 
Lime 
Glycerin 
Isopropyl alcohol 
Kaolin 
Lauric diethanolamide 
Methylparaben 
Sodium lauryl sulfate 
Water 
Zinc Oxide 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-210-021 in 1 BOX
150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H03/01/2010
Labeler - Glytone (117196928)

Revised: 1/2011
 
Glytone