Label: SALLY HANSEN OUCH-RELIEF STRIPLESS HARD WAX KIT- benzocaine kit

  • NDC Code(s): 66184-161-01, 66184-163-01
  • Packager: Coty US LLC
  • 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 July 5, 2023

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  • SPL UNCLASSIFIED SECTION

    (Ouch-Relief™ Numbing Wipe)

  • 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 Stripless Hard Wax Kit Label

    OUCH-RELIEF™
    STRIPLESS HARD WAX KIT

    PAIN-
    RELIEF
    TECHNOLOGY™

    Sally Hansen ®

    FOR FACE & BODY

    Pre-Treatment Helps
    Reduce Pain While
    Waxing

    Results Last Up to
    8 Weeks!*

    Body Contouring
    Formula Eliminates
    Coarse Hair

    *Individual hair re-growth results may vary

    Wax NET WT. 4.0 oz 113 g,

    3 Ouch-Relief™ Numbing Wipes,
    6 Spatulas, 4 Azulene Oil Finish Wipes,
    Instructions

    Dermatologist & Salon Tested

    Principal Display Panel - Sally Hansen Ouch-Relief Stripless Hard Wax Kit Label
  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN OUCH-RELIEF STRIPLESS HARD WAX KIT 
    benzocaine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-161
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66184-161-011 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 PACKET 4 
    Part 31 JAR 113.4 g
    Part 1 of 3
    OUCH-RELIEF NUMBING WIPE 
    benzocaine cloth
    Product Information
    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 OIL FINISHING WIPE 
    other skin care preparations
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    INGRWHEAT GERM OIL (UNII: 14C97E680P)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGRGUAIAZULENE (UNII: 2OZ1K9JKQC)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 PACKET; 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 
    other skin care preparations
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRGLYCERYL ROSINATE (UNII: SD112V492J)  
    INGRPARAFFIN (UNII: I9O0E3H2ZE)  
    INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
    INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRMICA (UNII: V8A1AW0880)  
    INGROAT KERNEL OIL (UNII: 3UVP41R77R)  
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    INGRGERANIOL (UNII: L837108USY)  
    INGR.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    INGRBENZYL BENZOATE (UNII: N863NB338G)  
    INGRISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRPENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1113.4 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34810/18/2018
    Labeler - Coty US LLC (039056361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crystal Claire Cosmetics Inc.205493484manufacture(66184-161)
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