Label: DR. THROWERS SKIN LIGHTENING MOISTURIZING- hydroquinone lotion

  • 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 May 22, 2015

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  • ACTIVE INGREDIENT

    HYDROQUINONE 2%

  • PURPOSE

    SKIN LIGHTENING

  • USES:

    FOR THE GRADUAL FADING OF DARK AREAS IN THE SKIN SUCH AS FRECKLES, AGE AND LIVER SPOTS.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES.
    • SOME USERS OF THIS PRODUCT MAY EXPERIENCE SKIN IRRITATION. IF SKIN IRRITATION BECOMES SEVERE, STOP USE AND CONSULT A DOCTOR.

    DO NOT USE

    • ON CHILDREN UNDER 12 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    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.

  • INACTIVE INGREDIENTS:

    WATER, PROPYLENE GLYCOL, CETYL ALCOHOL, MINERAL OIL, GLYCERYL STEARATE, CETEARYL ALCOHOL, CETEARETH-20, POTATO STARCH MODIFIED, DIMETHICONE, FRAGRANCE, PHENOXYETHANOL, TRIMETHYLPROPANEDIOL/ADIPIC ACID COPOLYMER, LANOLIN, SODIUM METABISULFITE, METHYLPARABEN, CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL, TETRASODIUM EDTA, PHOSPHOLIPIDS, TOCOPHERYL ACETATE, RETINYL ACETATE, ASCORBYL PALMITATE, CITRIC ACID.

  • PRINCIPAL DISPLAY PANEL

    SKIN LIGHTENING MOISTURIZING LOTION_front

    SKIN LIGHTENING MOISTURIZING LOTION_Back

  • INGREDIENTS AND APPEARANCE
    DR. THROWERS SKIN LIGHTENING MOISTURIZING 
    hydroquinone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69299-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARETH-22 (UNII: 28VZG1E234)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GRAPEFRUIT PEEL (UNII: 3582N05Q44)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69299-302-31201 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A05/15/2015
    Labeler - DR. THROWER'S SKINCARE, INC. (078711495)
    Registrant - DR. THROWER'S SKINCARE, INC. (078711495)
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