Glytone essentials Skin bleaching fading

Dosage form: lotion
Ingredients: HYDROQUINONE 1.2mL in 60mL
Labeler: Genesis Pharmaceutical
NDC Code: 64760-229

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.

Glytone essentials skin bleaching fading



Warnings

For external use only

Do not use on children under the age of 12 unless directed by a doctor.

When using this product

  • Avoid contact with eyes. If contact occurs, rinse eyes throughly with water.
  • A mild skin irritation may occur
  • Avoid unnecessary sun exposure and use a sunscreen
Stop use and ask a doctor if
  • too much skin irritation or sensitivity develops and increases
  • a gradual blue-black darkening of the skin occur
  • If pregnant or breast feeding, ask a health professional before use
  • Keep out of reach of children
If swallowed get medical help or contact a Poison Control Center right away.



Inactive Ingredients

BHA, BHT, Disodium EDTA, Glycolic acid, hydroxyethyl ethylcellulose, Isopropyl Alcohol, Kojic Acid, Nordihydroguaiaretic Acid, Octoxynol-9,Propylene Glycol, Water (Aqua), Sodium Bisulfite, Sodium metabisulfite.



sunburn alert

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.



Active ingredients       Purpose

Hydroquinone 2%        Skin bleaching



Use  lightens discolorations



Directions

Adults: apply a thin layer on the affected area twice daily or as directed by a doctor

If no improvement is seen after 3 months of treatment, use of this product should be discontinued

Lightening effect of this product may not be noticeable when used on very dark skin.

Keep out of reach of children.



Skin bleaching



Adults: Apply a thin layer on the affected area twice daily or as directed by a doctor.


glytone essentials

skin bleaching

fading lotion

2% hydroquinone

60mle/ 2 fl. oz.

GLYTONE ESSENTIALS SKIN BLEACHING FADING 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-229
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE1.2 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
BUTYLATED HYDROXYTOLUENE 
EDETATE DISODIUM 
GLYCOLIC ACID 
ETHYLCELLULOSES 
ISOPROPYL ALCOHOL 
KOJIC ACID 
OCTOXYNOL 9 
PROPYLENE GLYCOL 
SODIUM BISULFITE 
SODIUM METABISULFITE 
Packaging
#Item CodePackage Description
1NDC:64760-229-0160 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A05/20/2010
Labeler - Genesis Pharmaceutical (117196928)
Establishment
NameAddressID/FEIOperations
Genesis Pharmaceutical117196928manufacture

Revised: 03/2011
 
Genesis Pharmaceutical

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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