Label: DERMISA SKIN FADE VITAMIN C INFUSED- hydroquinone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68343-005-01, 68343-005-02, 68343-005-25, 68343-005-50 - Packager: Montani Cosmetics 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 July 18, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Keep out of reach of children
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Directions
• Adults Apply a small amount as a thin layer to the affected areas twice daily or 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 prevent bleached skin after treatment completed to prevent darkening from recurring
- Other Information
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Inactive ingredients
Water (Aqua), Glycerin, Paraffinum Liquidum (Mineral Oil), Stearyl Alcohol, Petrolatum, Cetearyl Alcohol, Steareth-10, Propylene Glycol, Steareth-2, Sodium Sulfite, Citric Acid, Sodium Metabisulphate, Diazolidinyl Urea, Dicetyl Phosphate, Ceteth-10 Phosphate, Fragrance (Parfum), Methylparaben, Propylparaben, Ethylhexyl Methoxyinnamate, Limonene, Hydroxycitronellol, Ascorbic Acid (Vitamin C)
- Package Label
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INGREDIENTS AND APPEARANCE
DERMISA SKIN FADE VITAMIN C INFUSED
hydroquinone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68343-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 2 g in 100 g Inactive Ingredients Ingredient Name Strength DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LIMONENE, (+)- (UNII: GFD7C86Q1W) SODIUM SULFITE (UNII: VTK01UQK3G) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) OCTINOXATE (UNII: 4Y5P7MUD51) HYDROXYCITRONELLOL (UNII: R0B4U2I48W) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) GLYCERIN (UNII: PDC6A3C0OX) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PETROLATUM (UNII: 4T6H12BN9U) STEARETH-10 (UNII: FD0913P475) STEARETH-2 (UNII: V56DFE46J5) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68343-005-01 1 in 1 BOX 07/16/2018 1 NDC:68343-005-50 50 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68343-005-02 1 in 1 BOX 07/16/2018 2 NDC:68343-005-25 25 g 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 07/16/2018 Labeler - Montani Cosmetics Inc (124852331)