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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64760-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydroquinone (hydroquinone) hydroquinone40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL 
GLYCERIN 
PETROLATUM 
PROPYLENE GLYCOL 
MINERAL OIL 
SODIUM LAURYL SULFATE 
SODIUM METABISULFITE 
SORBIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-200-011 in 1 BOX
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A04/01/2010
Labeler - Glytone (117196928)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Pharmaceuticals117196928manufacture

Revised: 3/2010
Document Id: 1912367c-011c-4ada-bd7a-057ed148d4b8
Set id: f1fd0340-7975-435f-9de8-3064c6e2250e
Version: 2
Effective Time: 20100304
 
Glytone