GLYTONE ACNE- resorcinol and sulfur lotion
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

Active Ingredients

Sulfur 8.0%

Resorcinol 2.0%

Purpose

Acne Treatment

Uses

Penetrates pores to control acne blemishes, pimples, blackheads, and whiteheads.
Helps keep skin clear of new acne blemishes, pimples, blackheads and whiteheads.
Dries and clears and reduces the severity of acne blemishes, pimples, blackheads, and whiteheads and allow skin to heal.
Helps prevent new acne blemishes, pimples, blackheads, and whiteheads from forming.
Helps prevent the development of new acne blemishes, pimples, blackheads and whiteheads.

Warnings

For external use only

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.

Stop use and ask a doctor if

Rash or irritation develops

Apply to affected areas only. Do not use on broken skin. Do not apply to large areas of the body.Flammable-Keep away from open fire or flame.

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 medication.
Cover the affected area with a thin layer one to three times a day. Because drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.

Inactive Ingredients

Acetone, Chloroxylenol, Fragrance (Parfum), Iron Oxides, Isopropyl Alcohol, Magnesium Aluminum Silicate, Octoxynol-9, Propylene glycol, titanium dioxide, Water (aqua), xanthan gum.

Principal Display Panel

Glytone Acne treatment

flesh tinted acne lotion

sulfur and resorcinol

2 fl oz/ 60 ml

exclusive to physicians

Pierre Fabre

Distribute by:

Genesis Pharmaceutical Inc

Parsippany, NJ 07054

Made in USA

1-800-459-8663

www.glytone-usa.com

GLYTONE ACNE
sulfur, resorcinol lotion

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:64760-000
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RESORCINOL (RESORCINOL)	RESORCINOL	20 mg in 1 mL
SULFUR (SULFUR)	SULFUR	80 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ACETONE
CHLOROXYLENOL
ISOPROPYL ALCOHOL
MAGNESIUM ALUMINUM SILICATE
OCTOXYNOL-9
PROPYLENE GLYCOL
TITANIUM DIOXIDE
WATER
XANTHAN GUM

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64760-000-35	60 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	07/11/2012	07/31/2014

Labeler - Genesis Pharmaceutical, Inc. (117196928)

Revised: 8/2014

Document Id: acd7dc88-bca0-422f-8ba4-eddd1e424690

Set id: 8c9530e8-de94-47a8-b3e3-f7207fefc097

Version: 4

Effective Time: 20140807

Genesis Pharmaceutical, Inc.