gloTriple Action Serum

Dosage form: gel
Ingredients: HYDROQUINONE 20mg in 1g
Labeler: CoValence Inc.
NDC Code: 66915-414

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.

Drug Facts

Active Ingredient:

Hydroquinone 2%

Inactive Ingredients:

Aqua (Water), Hamamelis Virginiana (Witch Hazel) Water, Alcohol Denat., Glycerin, Ascophyllum Nodosum Extract, Polyglyceryl-4 Caprate, Glycolic Acid, Retinol, Xanthan Gum, Elaeis Guineensis (Palm) Oil, Tocopherol (D-alpha), Tocotrienols, Polysorbate 20, Gluconolactone, Calcium Gluconate, Sodium Benzoate

Purpose:

Skin Bleaching Serum

Keep Out of Reach of Children
  • Do not use on children less than 12 years of age unless directed by a doctor.

Indications:
  • For the gradual fading of discolorations or areas  in the skin such as freckles or age and liver spots.

Warnings:
  • Avoid contact with eyes.
  • Some users of this product may experience a mild skin irriatation.  If skin irritation become severe, stop use and consult a doctor.

Directions:
  • Adults:  apply a small amount as a thin layer on the affeced area twice daily, or use 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.  
  • 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 darkeing from reoccurring.
  • Apply a small amount to target areas up to twice daily. Limit daily use to 6 months, wait 1-2 months before resuming treatment.

glōProfessional
Denver, CO 80223 Dist.
MADE IN USA
Caleel+Hayden
Naritaweg 165 1043 BW
Amsterdam Nederland

GLOTRIPLE ACTION SERUM 
hydroquinone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-414
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER1 g  in 1 g
WITCH HAZEL1 g  in 1 g
ALCOHOL1 g  in 1 g
GLYCERIN1 g  in 1 g
POLYGLYCERYL-4 ISOSTEARATE1 g  in 1 g
GLYCOLIC ACID1 g  in 1 g
RETINOL1 g  in 1 g
POLYSORBATE 201 g  in 1 g
ASCOPHYLLUM NODOSUM1 g  in 1 g
.ALPHA.-TOCOPHEROL, D-1 g  in 1 g
TOCOTRIENOLS1 g  in 1 g
ELAEIS OLEIFERA SEED OIL1 g  in 1 g
GLUCONOLACTONE1 g  in 1 g
XANTHAN GUM1 g  in 1 g
SODIUM BENZOATE1 g  in 1 g
Packaging
#Item CodePackage Description
1NDC:66915-414-041 BOTTLE, GLASS (BOTTLE) in 1 CARTON
1NDC:66915-414-0130 g in 1 BOTTLE, GLASS
2NDC:66915-414-03200000 g in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A10/01/2009
Labeler - CoValence Inc. (070653204)

Revised: 01/2014
 
CoValence 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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