Label: SALLY HANSEN OUCH-RELIEF  WAX STRIP 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

    Close
  • Active ingredient

    6% Benzocaine

    Close
  • Purpose

    Topical Analgesic

    Close
  • Uses

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

    Close
  • 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

    Close
  • 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 raw surfaces, or blistered areas

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • 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

    Close
  • Other information

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

    Close
  • Inactive ingredients

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

    Close
  • Questions or comments?

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

    Close
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Kit Label

    OUCH-RELIEF™
    WAX STRIP KIT

    PAIN-
    RELIEF
    TECHNOLOGY™

    FOR BODY
    Pre-Treatment
    for Pain-Free
    Hair Removal

    Results Last
    up to
    8 Weeks!*

    Ready &
    Easy to Use

    *Individual hair re-growth results may vary

    Body
    Contouring
    Strip

    32 Wax Strips

    Total 16 double-sided, 4 Benzocaine wipes, Azulene Finishing Oil 0.5 fl oz 14.7 ml, Instructions

    Dermatologist & Salon Tested

    Principal Display Panel – Kit Label
    Close
  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN OUCH-RELIEF   WAX STRIP KIT
    benzocaine kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66184-154
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66184-154-01 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 PACKET
    Part 2 1 PACKET 32 
    Part 1 of 2
    OUCH-RELIEF WAX STRIP KIT 
    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 STRIP KIT 
    depilatories strip
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR Rosin  
    INGR Mineral Oil  
    INGR High Density Polyethylene  
    INGR Castor Oil  
    INGR Sunflower Oil  
    INGR Isopropyl Myristate  
    INGR LINALOOL, (+/-)-  
    INGR .ALPHA.-HEXYLCINNAMALDEHYDE  
    INGR PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)  
    INGR ISOMETHYL-.ALPHA.-IONONE  
    INGR CYMBIDIUM HOOKERIANUM FLOWER  
    INGR Almond Oil  
    INGR Rosemary  
    INGR BUTYLATED HYDROXYTOLUENE  
    INGR FD&C YELLOW NO. 6  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 32 in 1 PACKET
    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(66184-154)
    Close