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

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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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

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

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 BOX12/15/2018
1177.4 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A12/15/2018
Labeler - Elements Brands, Inc. (006166707)

Revised: 12/2018
Document Id: 7e07d83d-9ac3-68bd-e053-2991aa0a320c
Set id: b70164e1-433c-420a-b848-1cbefa9278b3
Version: 2
Effective Time: 20181227
 
Elements Brands, Inc.