Label: BEST AGE SPOT REMOVER- hydroquinone cream
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- 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.
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- Drug Facts
- Active Ingredient
- Uses:
- Warnings:
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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:
-
INGREDIENTS AND APPEARANCE
BEST AGE SPOT REMOVER
hydroquinone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72364-346 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72364-346-00 1 in 1 BOX 06/01/2018 04/30/2023 1 56 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 06/01/2018 04/30/2023 Labeler - M&M Beauty and Wellness, LLC (080441602)
