Label: SALLY HANSEN OUCH-RELIEF WAX STRIP KIT- benzocaine kit

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

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 19, 2021

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  • 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 raw 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

    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
  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN OUCH-RELIEF   WAX STRIP KIT
    benzocaine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-154
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66184-154-011 in 1 CARTON; Type 0: Not a Combination Product01/01/2012
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 5 
    Part 21 PACKET 32 
    Part 1 of 2
    OUCH-RELIEF WAX STRIP KIT 
    benzocaine cloth
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.0543 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B
    Part 2 of 2
    OUCH-RELIEF WAX STRIP KIT 
    depilatories strip
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRROSIN (UNII: 88S87KL877)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRHIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    INGRCASTOR OIL (UNII: D5340Y2I9G)  
    INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
    INGRISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGR.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    INGRPENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    INGRISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    INGRCYMBIDIUM HOOKERIANUM FLOWER (UNII: H2DJ03DI5I)  
    INGRALMOND OIL (UNII: 66YXD4DKO9)  
    INGRROSEMARY (UNII: IJ67X351P9)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGRFD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    132 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/01/2012
    Labeler - Coty US LLC (039056361)
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