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Package Insert and Label Information: Glytone Acne Treatment

By Glytone | Last revised: 14 January 2011

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.


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
(click image for full-size original)

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 Type HUMAN OTC DRUG Item Code (Source) NDC:64760-210
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sulfur (sulfur) sulfur 9 g in 141 g
Inactive Ingredients
Ingredient Name Strength
Bentonite
Lime
Glycerin
Isopropyl alcohol
Kaolin
Lauric diethanolamide
Methylparaben
Sodium lauryl sulfate
Water
Zinc Oxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64760-210-02 1 TUBE (TUBE) in 1 BOX contains a TUBE
1 50 g in 1 TUBE This package is contained within the BOX (64760-210-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 03/01/2010
Labeler — Glytone (117196928)

Revised: 01/2011 Glytone

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