GLYTONE CLARIFYING  - hydroquinone gel 
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 Skin bleaching Clarifying



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



Warnings Contains Sodium Bisulfite, a sulfite that may cause serious allergic type reactions (eg hives, itching, wheezing, anaphlyaxis, severe asthma attack) in certain susceptible persons.



Contains Each gram of Clarifying Gel contains 40 mg of Hydroquinone USP in a gel base of Purified Water, Propylene Glycol, Carbomer 940, Sodium Bisulfite, Edetate Disodium, Sorbic Acid, Glycerin.



Distributed by Genesis Pharmaceutical Inc

Parsippany, NJ 07054

Made in USA

18004598663


gel carton

NDC 64760 202 01

Glytone skin bleaching clarifying gel

rx only

hydroquinone usp 4%

Net wt. 2oz. (56 g)

GLYTONE CLARIFYING  
hydroquinone gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64760-202
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydroquinone (Hydroquinone) Hydroquinone40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
CARBOMER HOMOPOLYMER TYPE C 
SODIUM BISULFITE 
EDETATE DISODIUM 
SORBIC ACID 
GLYCERIN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-202-011 in 1 BOX
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A11/09/2010
Labeler - Glytone (117196928)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Pharmaceutical117196928manufacture

Revised: 3/2010
Document Id: d4366402-fd05-48e3-a16c-c4355d2b4ffc
Set id: ad96d53f-431f-439f-9948-784f467b53dc
Version: 2
Effective Time: 20100310
 
Glytone