Label: SALLY HANSEN OUCH-RELIEF  WAX KIT - benzocaine   

  • Label RSS
  • 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

    6% 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. Not intended for use by children under 13 years of age

    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
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  • Do not use

    • 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

    • Rub well (see enclosed instructions)
    • Use wipes no more than 3 to 4 times daily.

    Discard wipe after use.

    Adults and children 13 years of age and older apply to the area to be treated 10 minutes before hair removal

    Children under 13 years of age consult a doctor

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  • Other information

    As with all products containing benzocaine, localized allergic reactions may occur after prolonged or repeated use.

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  • Inactive ingredients

    ALCOHOL DENAT., AQUA/WATER/EAU, PROPYLENE GLYCOL, METHYLPARABEN

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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

    New

    OUCH-RELIEF™
    WAX KIT

    PAIN-
    RELIEF
    TECHNOLOGY

    FOR FACE AND BODY
    Pre-Treatment
    Helps Reduce Pain
    while Waxing

    Results Last Up to
    8 Weeks!*

    Simply Rinses Off
    with Water

    *Individual hair re-growth
    results may vary

    Wax Net wt. 6.7 oz 189.9 g, 5 Benzocaine wipes,
    20 Strips, 1 Spatula for face and body, Instructions

    Dermatologist & Salon Tested

    Principal Display Panel – Kit Label
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  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN OUCH-RELIEF   WAX KIT
    benzocaine kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66184-153
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66184-153-01 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 PACKET
    Part 2 1 JAR 189.9 g
    Part 1 of 2
    OUCH-RELIEF 
    benzocaine cloth
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzocaine (Benzocaine) Benzocaine 0.0543 g
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol  
    Water  
    Denatonium Benzoate  
    Propylene Glycol  
    Methylparaben  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 5 in 1 PACKET
    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
    OUCH RELIEF   WAX KIT
    depilatories
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR Fructose  
    INGR Dextrose  
    INGR Invert Sugar  
    INGR Sucrose  
    INGR Water  
    INGR Phenoxyethanol  
    INGR Glycerin  
    INGR Mica  
    INGR Ethylhexylglycerin  
    INGR Titanium Dioxide  
    INGR honey  
    INGR Acetic Acid  
    INGR Coumarin  
    INGR Tocopherol  
    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(66184-153)
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