Label: SCARLIGHT MD- hydroquinone liquid

  • 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 December 29, 2009

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  • Active Ingredients

    Hydroquinone 2%

  • Purpose

    Skin Lightener

  • Uses

    • lightens dark (brownish) discoloration in the skin such as age and liver spots
  • Warnings

    For external use only

  • Do not use

    • on children under 12 years of age.  Consult a doctor.
    • on mucous membranes
  • When using this product

    • mild irritation may occur
    • avoid contact with eyes.  If contact occurs, rinse with water.
  • Stop use and ask a doctor if

    • irritation becomes severe
    • condition worsens
  • Keep out of reach of children.

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

  • Directions

    • adults: brush a small amount twice daily. Rub in.
    • limit sun exposure and use a sunscreen, a sun blocking agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring
    • discontinue if symptoms persist for more than 3 months
    • children under 12 years of age, consult a doctor before use
  • Other Information

    • store at 15º to 30ºC (59 to 86ºF)
    • keep bottle tightly closed or product will evaporate
  • Inactive Ingredients

    retinoic acid, melatonin, MSM, BHT, na metabisulfite, arbutin, cystamine, licorice root, dandelion root, hydroxyanisole, ascorbic acid, hydroxypropylcellulose, kojic acid, azelaic acid, acetone, propylene glycol, ethyl alcohol (SDA), distilled water q.s.

  • Questions

    call

    1-877-566-5935
  • Carton 15mL

    15mL Label

  • Carton 30mL

    30mL Label

  • INGREDIENTS AND APPEARANCE
    SCARLIGHT MD 
    hydroquinone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64269-9902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) HYDROQUINONE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Alcohol (UNII: 3K9958V90M)  
    Acetone (UNII: 1364PS73AF)  
    Azelaic Acid (UNII: F2VW3D43YT)  
    Hydroxypropyl Cellulose (UNII: RFW2ET671P)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Butylated Hydroxyanisole (UNII: REK4960K2U)  
    TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU)  
    Licorice (UNII: 61ZBX54883)  
    Arbutin (UNII: C5INA23HXF)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Melatonin (UNII: JL5DK93RCL)  
    Tretinoin (UNII: 5688UTC01R)  
    Water (UNII: 059QF0KO0R)  
    Kojic Acid (UNII: 6K23F1TT52)  
    Cystamine (UNII: R110LV8L02)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64269-9902-830 mL in 1 BOTTLE, WITH APPLICATOR
    2NDC:64269-9902-715 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35811/01/2002
    Labeler - Scarguard Labs, LLC (842204575)
    Registrant - Scarguard Labs, LLC (842204575)
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