Label: EB5 AGE SPOT TREATMENT- hydroquinone cream
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- NDC Code(s): 71221-995-06
- Packager: Elements Brands, Inc.
- 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
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- Drug Facts
- Active ingredient
- Uses
- Warnings
- SPL UNCLASSIFIED SECTION
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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.
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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.
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INGREDIENTS AND APPEARANCE
EB5 AGE SPOT TREATMENT
hydroquinone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71221-995 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 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71221-995-06 1 in 1 BOX 12/15/2018 10/31/2023 1 177.4 mL in 1 TUBE; 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 12/15/2018 10/31/2023 Labeler - Elements Brands, Inc. (006166707)
