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

    (Benzocaine Wipes)

  • 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 - Sally Hansen Ouch-Relief Wax Strip Kit Label

    OUCH-RELIEF™
    WAX STRIP KIT

    WAX

    PAIN-
    RELIEF
    TECHNOLOGY™

    Sally Hansen ®

    FOR FACE
    & BIKINI

    Pre-Treatment
    for Pain-Free
    Hair Removal

    Results Last
    Up to
    8 Weeks!*

    Ready &
    Easy to Use

    *Individual hair
    re-growth results
    may vary

    Contouring
    Strip

    24 Wax
    Strips

    2
    Sizes

    Total 12 double sided, 3 Benzocaine wipes,
    Azulene Finishing Oil 0.5 fl oz 14.7 ml, Instructions

    Dermatologist & Salon Tested

    Principal Display Panel - Sally Hansen Ouch-Relief Wax Strip Kit Label
  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN OUCH-RELIEF WAX STRIP KIT 
    benzocaine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-162
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66184-162-011 in 1 CARTON; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 APPLICATOR 3 
    Part 21 JAR 14.17 g
    Part 32 PACKET 24 
    Part 1 of 3
    OUCH-RELIEF NUMBING WIPE 
    benzocaine cloth
    Product Information
    Item Code (Source)NDC:66184-163
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66184-163-013 in 1 PACKET
    11 in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34810/18/2018
    Part 2 of 3
    AZULENE FINISHING OIL INGREDIENTS 
    other skin care preparations oil
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    INGRSESAME OIL (UNII: QX10HYY4QV)  
    INGRC13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRMENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRETHYLPARABEN (UNII: 14255EXE39)  
    INGRGUAIAZULENE (UNII: 2OZ1K9JKQC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114.17 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic10/18/2018
    Part 3 of 3
    WAX STRIP 
    other skin care preparations strip
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRROSIN (UNII: 88S87KL877)  
    INGRGLYCERYL ROSINATE (UNII: SD112V492J)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRHIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic10/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34810/18/2018
    Labeler - Coty US LLC (039056361)
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