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Name:Glytone Clarifying
Manufacturer:Glytone
Category:Prescription Marketed Drugs


Glytone clarifying skin Bleaching

GLYTONE CLARIFYING   - hydroquinone 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 clarifying skin Bleaching



Dosage Apply Clarifying Cream nightly to the affected area or as directed by your physician.



Warnings contains sodium Metabisulfite, a sulfite that may cause serious allergic type reactions (eg hives, itching wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons.



Distributed by

Genesis Pharmaceutical Inc.

Parsippany, NJ 07054

Made in USA



Keep out of reach of children.



Store at controlled room temperature 15 30 C (59 86 F)



Contains each gram of Clarifying Cream contains 40 mg of Hydroquinone USP in a cream base of Purified Water, Cetostearly Alcohol, Glycerin, Petrolatum, Propylene Glycol, Mineral Oil, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sorbic acid.

label


NDC 64760-200-01

Glytone Clarifying skin Bleaching Clarifying Cream

Hydroquinone USP, 4%

Rx Only

Net wt. 2 oz. (56g)


GLYTONE CLARIFYING  
hydroquinone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64760-200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hydroquinone (hydroquinone) hydroquinone 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL  
GLYCERIN  
PETROLATUM  
PROPYLENE GLYCOL  
MINERAL OIL  
SODIUM LAURYL SULFATE  
SODIUM METABISULFITE  
SORBIC ACID  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64760-200-01 1 TUBE ( TUBE) in 1 BOX contains a TUBE
1 56 g in 1 TUBE This package is contained within the BOX (64760-200-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part358A 04/01/2010

Labeler - Glytone (117196928)
Establishment
Name Address ID/FEI Operations
Genesis Pharmaceuticals 117196928 manufacture

Revised: 03/2010 Glytone



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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