Label: OLIVIA QUIDO SKINCARE BLEMISH ERASER- 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 27, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Hydroquinone, 2%

  • Purpose

    Skin Lightening

  • Uses

    For the gradual fading of dark blemishes in the skin such as age spots, freckles, liver spots.

  • Warnings

    For external use only.

    Do Not Use on Children - under 12 years old of age unless directed by a physician.

    Do not use on children - under 12 years of age unless directed by a physician.

    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 eyes. Rinse water to remove.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults: apply a small amount as a thin layer on the affected area twice daily, or use as directed by a physician.
    • 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 dark skin.
    • Children under 12 years old: do not use unless directed by a physician.
    • 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 reoccurring.
  • Other Information

    • Store at a controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.
  • Inactive Ingredients

    4-Butylresorcinol, Aloe Barbadensis Leaf Juice, BHT, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes, Ceramide - NP, Cetyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Citric Acid, Diazolidinyl Urea, Dimethyl Isosorbide, Glycerin, Hexyl Laurate, Iodopropnyl Butylcarbamate, Kojic Acid, Laureth-23, Laureth-7, Maltodextrin, Phenoxyethanol, Polyacrylamide, Polyglyceryl-4 Isostearate, Polysorbate 20, Retinol, Silica, Sodium Hyaluronate, Sodium Hydroxide, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Trideceth-6 Phosphate, Triethylene Glycol, Water/Aqua.

  • PRINCIPAL DISPLAY PANEL

    OSCBE

  • INGREDIENTS AND APPEARANCE
    OLIVIA QUIDO SKINCARE BLEMISH ERASER 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71421-501
    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
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    RETINOL (UNII: G2SH0XKK91)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TRIDECETH-6 PHOSPHATE (UNII: NKT96BX1OC)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    4-BUTYLRESORCINOL (UNII: 2IK4UQ3ZGA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    KOJIC ACID (UNII: 6K23F1TT52)  
    LAURETH-23 (UNII: N72LMW566G)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71421-501-301 in 1 CARTON07/27/2021
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A07/27/2021
    Labeler - O Skin Care LLC (021275401)
    Registrant - V Manufacturing & Logistics, Inc. (825176857)
    Establishment
    NameAddressID/FEIBusiness Operations
    V Manufacturing & Logistics, Inc.825176857manufacture(71421-501)