EB5 AGE SPOT TREATMENT- hydroquinone cream 
Elements Brands, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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EB5 Age Spot Treatment

Drug Facts

Active ingredient

Hydroquinone 2%

Purpose

Skin lightener

Uses

Lightens dark spots in the skin such as freckles, age spots an liver spots.

Warnings

  • For external use only.
  • Avoid contact with eyes or eyelids.
  • Some users of this product may experience milld skin irritation. Consult physician if skin irritation becomes severe.

Do not use 

  • on children under 12, unless directed by physician

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

Store at room temperature.

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 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 or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from recurring.

Other Ingredients:

Acer Saccharum (Sugar Maple) Extract, Aminomethyl Propanol, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Caprylic/Capric/Myristic/Stearic Triglyceride, Carbomer, Cetearyl Alcohol, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limonum (Lemon) Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Glycerin, Octisalate, Oleth-5 Phosphate, Phenoxyethanol, Saccharum Officinarum (Sugar Cane) Extract, Sodium Metabisulfite, Steareth-21, Stearyl Alcohol, Vaccinium Myrtillus (Bilberry) Extract.

Question of Comments?

1-800-683-2325, M-F, 8am-5pm PST.

Package Labeling:

Label

EB5 AGE SPOT TREATMENT 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71221-995
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
WATER (UNII: 059QF0KO0R)  
ARGAN OIL (UNII: 4V59G5UW9X)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ORANGE (UNII: 5EVU04N5QU)  
LEMON (UNII: 24RS0A988O)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTISALATE (UNII: 4X49Y0596W)  
OLETH-5 PHOSPHATE (UNII: 44FE98F6UX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SUGARCANE (UNII: 81H2R5AOH3)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
BILBERRY (UNII: 9P2U39H18W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71221-995-061 in 1 BOX12/15/201811/30/2020
1177.4 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/15/201811/30/2020
Labeler - Elements Brands, Inc. (006166707)

Revised: 10/2023
Document Id: 0722dc76-e7aa-274d-e063-6294a90a84b4
Set id: b70164e1-433c-420a-b848-1cbefa9278b3
Version: 4
Effective Time: 20231007
 
Elements Brands, Inc.