Label: DERMISA SKIN FADE VITAMIN C INFUSED- hydroquinone cream

  • 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.

  • Active Ingredient

    Hydroquinone USP 2%

    Octyl Dimethyl Paba 0.60%

  • Purpose

    Skin Lightener

  • Uses

    Ÿ• ŸFŸor the gradual fading of dark (brownish) skin discolorations such as freckles, age and liver spots or uneven pigment that may occur due to sun overexposure, pregnancy or from the use of oral contraceptives.

  • Warnings

    For external use only

  • Do not use

    • On children under 12 years of age unless directed by a doctor • This product is not for use in the prevention of sunburn • On inflamed or broken skin

  • When using this product

    • Avoid contact with the eyes • Some users of this product may experience a mild skin irritation, if skin irritation becomes severe stop use and consult a doctor

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • 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

    • Store at room temperature • Tamper-evident tube • Contact us at contractar en info@dermisa.com

  • 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

    Carton Label

  • INGREDIENTS AND APPEARANCE
    DERMISA  SKIN FADE VITAMIN C INFUSED
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68343-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68343-005-011 in 1 BOX07/16/2018
    1NDC:68343-005-5050 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68343-005-021 in 1 BOX07/16/2018
    2NDC:68343-005-2525 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A07/16/2018
    Labeler - Montani Cosmetics Inc (124852331)