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Sally Hansen Ouch-Relief (Coty US LLC)

Available Formats

Dosage Form Package Information Links
KIT 1 KIT in 1 CARTON (66184-153-01) * 5 CLOTH in 1 PACKET * 189.9 g in 1 JAR Label Information

Complete Sally Hansen Ouch-Relief Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    6% Benzocaine


  • Purpose

    Topical Analgesic


  • Uses

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


  • 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

  • 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.


  • 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


  • Other information

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


  • Inactive ingredients

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


  • Questions or comments?

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


  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Kit Label

    New

    OUCH-RELIEFâ„¢
    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

  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN OUCH-RELIEF   WAX KIT
    benzocaine kit
    Product Information
    Product Type HUMAN OTC DRUG 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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 0.0543 g
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Denatonium Benzoate (UNII: 4YK5Z54AT2)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Methylparaben (UNII: A2I8C7HI9T)  
    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 (UNII: 6YSS42VSEV)  
    INGR Dextrose (UNII: IY9XDZ35W2)  
    INGR Invert Sugar (UNII: ED959S6ACY)  
    INGR Sucrose (UNII: C151H8M554)  
    INGR Water (UNII: 059QF0KO0R)  
    INGR Phenoxyethanol (UNII: HIE492ZZ3T)  
    INGR Glycerin (UNII: PDC6A3C0OX)  
    INGR Mica (UNII: V8A1AW0880)  
    INGR Ethylhexylglycerin (UNII: 147D247K3P)  
    INGR Titanium Dioxide (UNII: 15FIX9V2JP)  
    INGR honey (UNII: Y9H1V576FH)  
    INGR Acetic Acid (UNII: Q40Q9N063P)  
    INGR Coumarin (UNII: A4VZ22K1WT)  
    INGR Tocopherol (UNII: R0ZB2556P8)  
    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)