Label: SKIN BEAUTIFYING MILK- hydroquinone cream

  • Category: HUMAN OTC DRUG LABEL

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 October 28, 2015

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  • PRINCIPAL DISPLAY PANEL

    SkinMilk

  • SPL UNCLASSIFIED SECTION

  • Active Ingredient

    Hydroquinone 2.0%

  • Purpose

    Skin Lightener

  • Uses:

    • For an even toned glow by fading away skin discolorations such as age spots, freckles, or dark patches that may occur from pregnancy or the use of birth control pills.
  • Warnings

    For External use only.

    WHEN USING THIS PRODUCT

    • Avoid contact with eyes.
    • Avoid unnecessary sun exposure and use a sunscreen to prevent darkening from reoccuring.
    • Test overnight on Inside of elbow before use.
    • If skin irritation occurs, discontinue use and consult a doctor.
  • Do Not use on

    children under 12 years of age unless directed by a doctor.

  • Keep out of the reach of children.

    If swallowed, seek medical assistance.

  • Questions or Comments?

    1-800-423-0306 or sales@bluefieldInc.com

  • Directions

    • Spread a thin layer into patches on face, hands, arms or body..
    • Use twice daily or as directed by a doctor and in 4-6 weeks the effect should be evident.
    • Not for use on children under 12 except on doctor's intructions.
  • OTHER INFORMATION

    Close lid tightly after each use. Product may darken when exposed to air. This will not affect performance or safety.

  • Inactive Ingredients

    Water (Aqua), White Petrolatum, Cetyl Alcohol, Isopropyl Palmitate, Stearic Acid, Propylene Glycol, Stearic Acid, Ammonium Lauryl Sulfate, Dimethicone, Diazolidinyl Urea, Methylparaben, Propylparaben, Glyceryl Stearate,Sodium Metabisulfite, Ascorbic Acid, BHA, Propul Gallate,Trisodium EDTA, Fragrance (Parfum).

  • INGREDIENTS AND APPEARANCE
    SKIN BEAUTIFYING MILK 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16708-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16708-001-011 in 1 BOX
    1227 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A10/27/2015
    Labeler - Bluefield Associates, Inc. (626594667)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bluefield Associates, Inc.626594667manufacture(16708-001)
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