Label: SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT- benzocaine   

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    5% Benzocaine

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  • Purpose

    Topical analgesic

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  • Uses

    for temporary relief of pain and itching associated with minor skin irritations due to hair removal

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  • Warnings

    Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

    For external use only

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last for more than 7 days or clear up and occur again within a few days

    Do not use in

    • large quantities, over raws surfaces, or blistered areas

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

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  • Directions

    • shake well
    • use no more than 3 to 4 times daily

    Adults and children 2 years of age and older apply to treated area immediately after hair removal

    Children under 2 years of age consult a doctor

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  • Inactive ingredients

    Aqua/Water/Eau, Ethylhexyl Palmitate, Paraffinum Liquidum/ Mineral Oil/Huile Minerale, Propylene Glycol, Glyceryl Stearate, Cetyl Alcohol, Palmitic Acid, Triethanolamine, Stearic Acid, Imidazolidinyl Urea, Parfum/Fragrance, Peg-100 Stearate, Methylparaben, Carbomer, Tocopheryl Acetate, Lanolin Alcohol, Linalool, Benzyl Benzoate, Aloe Barbadensis Leaf Extract, Alcohol, Myristic Acid, Limonene, Geraniol, Citronellol, Eugenol, Citral, Soluble Collagen, Propylparaben, Citric Acid, Benzoic Acid, Tocopherol, BHT.

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  • Questions or comments?

    Call us at 1-800-953-5080 9:00AM - 5:00PM EST

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Kit Label

    MICROWABLE
    Eyebrow, Face & Lip
    WAX KIT

    WAX

    • Results last up
    to 8 weeks!*
    • With mini tweezers
    & brow guides

    Topical analgesic with
    5 % benzocaine

    des resultants
    jusqu'à 8 semaines !*
    • avec mini pince à épiler
    et guides pour les sourcils

    analgésique local avec
    5 % de benzocaïne

    *Individual results may vary
    *les resultants individuals prevent varier

    Wax / cire NET WT. 1.25 oz 35 g, Extrasoothe™ Lotion / lotion 0.5 fl oz 14.7 ml,
    Brow Guides / guides pour les sourcils, Temperature Indicator Applicator . applicateur avec indicateur
    de temperature, Mini Tweezers / mini pince à épiler, Orange Stick / bâtonnet orange, Instuctions

    Principal Display Panel – Kit Label
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  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT 
    benzocaine kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66184-155
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66184-155-01 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE 0.05 g
    Part 2 1 JAR 189.9 g
    Part 1 of 2
    SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT 
    benzocaine lotion
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzocaine (Benzocaine) Benzocaine 0.05 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    water  
    ethylhexyl palmitate  
    mineral oil  
    propylene glycol  
    glyceryl monostearate  
    cetyl alcohol  
    palmitic acid  
    trolamine  
    stearic acid  
    imidurea  
    peg-100 stearate  
    methylparaben  
    .ALPHA.-TOCOPHEROL ACETATE  
    lanolin alcohols  
    LINALOOL, (+/-)-  
    Benzyl Benzoate  
    aloe vera leaf  
    alcohol  
    myristic acid  
    geraniol  
    .BETA.-CITRONELLOL, (R)-  
    eugenol  
    citral  
    propylparaben  
    citric acid monohydrate  
    Benzoic Acid  
    tocopherol  
    butylated hydroxytoluene  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.05 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 01/01/2012
    Part 2 of 2
    SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT 
    depilatories strip
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR white wax  
    INGR calcium carbonate  
    INGR magnesium carbonate  
    INGR mineral oil  
    INGR canola oil  
    INGR coconut oil  
    INGR apricot kernel oil  
    INGR chamomile  
    INGR aloe vera leaf  
    INGR D&C Red No. 17  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 189.9 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 01/01/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 01/01/2012
    Labeler - Coty US LLC (789573201)
    Establishment
    Name Address ID/FEI Business Operations
    Coty US LLC 039056361 MANUFACTURE(66184-155)
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