Glytone skin bleaching fading

Dosage form: lotion
Ingredients: HYDROQUINONE 20mg in 1mL
Labeler: Genesis Pharmaceutical, Inc.
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 skin bleaching fading lotion

Drug Facts

Active ingredient

Hydroquinone 2.0% 

Purpose

Skin Bleaching

Use
  • Lightens dark (brownish) discolorations in the skin such as: freckles, age and liver spots or pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Warnings

For external use only

Allergy alert:

contains sulfites that may cause serious allergic type reactions such as hives, itching, wheezing, as severe asthma attack in certain susceptible persons.

Do not use

on children under 12 years of age unless directed by a doctor.

When using this product
  • avoid contact with eyes
  • some users may experience a mild skin irritation

Stop use and ask a doctor if
  • skin irritation becomes severe or allergic reactions occurs such as hives, itching or wheezing

Sunburn alert:

This product 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.

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Adults: apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen in 3 months of treatment, use of this product should be discontinued. Lightening effect of this product might not be noticeable when used on very dark skin.
  • Children under 12 years of age: do not use unless directed by a doctor.
  • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Other information
  • Protect the product in this container from excessive heat and direct sunlight
  • Questions? Call 1-800-459-8663. You may report serious side effects to this number.

Inactive Ingredients

Aminomethylpropanol, Disodium EDTA, Glycolic Acid, Hydroxyethyl Ethylcellulose, Isopropanol, Kojic Acid, Nordihydroguaiaretic Acid, Octoxynol-9, Propylene Glycol, Sodium Bisulfite, Sodium Metabisulfite, Water

Principal Display Panel - 60 mL Carton

GLYTONE

CLARIFYING

skin bleaching

fading lotion

2% hydroquinone

60 mL / 2 FL. OZ.

GLYTONE 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) HYDROQUINONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL 
EDETATE DISODIUM 
GLYCOLIC ACID 
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) 
ISOPROPYL ALCOHOL 
KOJIC ACID 
MASOPROCOL 
OCTOXYNOL-9 
PROPYLENE GLYCOL 
SODIUM BISULFITE 
SODIUM METABISULFITE 
WATER 
Packaging
#Item CodePackage Description
1NDC:64760-229-011 BOTTLE, PLASTIC in 1 CARTON
160 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart358A05/20/2010
Labeler - Genesis Pharmaceutical, Inc. (117196928)

Revised: 08/2014
 
Genesis Pharmaceutical, Inc.

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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