Label: SALLY HANSEN OUCH-RELIEF NUMBING WIPES- benzocaine cloth

  • 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 (Numbing 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 :he 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 - Carton Label

    OUCH-RELIEF™
    NUMBING WIPES

    PRE-WAX

    PAIN-
    RELIEF
    TECHNOLOGY

    FOR FACE
    & BODY

    Pre-Treatment
    Help Reduce
    Pain While Waxing

    Soothe &
    Prepare Skin
    Before Waxing

    Ready & Easy
    to Use

    9
    PRE-WAX
    WIPES

    Total 9 Ouch-Relief™ Numbing Wipes, Instructions

    Dermatologist & Salon Tested

    Principal Display Panel - Carton Label
  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN OUCH-RELIEF NUMBING WIPES 
    benzocaine cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-156
    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
    1NDC:66184-156-019 in 1 CARTON; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/01/2015
    Labeler - Coty US LLC (039056361)
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