Label: BEST AGE SPOT REMOVER- hydroquinone cream

  • NDC Code(s): 72364-346-00
  • Packager: M&M Beauty and Wellness, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated April 18, 2022

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Hydroquinone 2.00%

    Purpose

    Skin Lightener

  • Uses:

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

  • Warnings:

    • For external use only.

    • Avoid contact with eyes or eyelids.
    • Some users of this product may experience mild skin irritation. Discontinue use and consult a 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.

  • Directions:

    Adults: Apply a thin layer on the affected areas twice daily, or as directed by physician.
    • If no improvement is seen after three months of treatment, discontinue use of this product and consult physician.
    • Lightening effect of this product may be less noticeable on very dark skin.
    • Children under 12-years of age: Do not use this product unless directed by physician.
    • Sun exposure should be limited by using sunscreen agent, 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 Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Butylene Glycol, Cetyl Alcohol, Cetyl Phosphate, Citric Acid, Coco-Caprylate/Caprate, Diazolidinyl Urea, Dimethicone, Glycerin, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Methyl Paraben, Octinoxate, Propyl Paraben, Propylene Glycol, Sodium Ascorbyl Phosphate (Vitamin C), Rosa Canina (Rose Hips) Oil, Sodium Metabisulfite, Sodium PCA, Stearic Acid, Tetrasodium EDTA, Tocopheryl Acetate
    (Vitamin E), Vitis Vinifera (Grape) Seed Extract.

  • SPL UNCLASSIFIED SECTION

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BEST AGE SPOT REMOVER 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72364-346
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GRAPE (UNII: 6X543N684K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72364-346-001 in 1 BOX06/01/201804/30/2023
    156 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A06/01/201804/30/2023
    Labeler - M&M Beauty and Wellness, LLC (080441602)