Label: SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT- benzocaine kit

  • Category: HUMAN OTC DRUG LABEL

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 May 25, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    5% 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

    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 in

    • large quantities, 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

    • shake well
    • use no more than 3 to 4 times daily

    Adults and children 2 years of age and older apply to treated area immediately after hair removal

    Children under 2 years of age consult a doctor

  • Inactive ingredients

    Aqua/Water/Eau, Ethylhexyl Palmitate, Paraffinum Liquidum/ Mineral Oil/Huile Minerale, Propylene Glycol, Glyceryl Stearate, Cetyl Alcohol, Palmitic Acid, Triethanolamine, Stearic Acid, Imidazolidinyl Urea, Parfum/Fragrance, Peg-100 Stearate, Methylparaben, Carbomer, Tocopheryl Acetate, Lanolin Alcohol, Linalool, Benzyl Benzoate, Aloe Barbadensis Leaf Extract, Alcohol, Myristic Acid, Limonene, Geraniol, Citronellol, Eugenol, Citral, Soluble Collagen, Propylparaben, Citric Acid, Benzoic Acid, Tocopherol, BHT.

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Kit Label

    MICROWABLE
    Eyebrow, Face & Lip
    WAX KIT

    WAX

    • Results last up
    to 8 weeks!*
    • With mini tweezers
    & brow guides

    Topical analgesic with
    5 % benzocaine

    des resultants
    jusqu'à 8 semaines !*
    • avec mini pince à épiler
    et guides pour les sourcils

    analgésique local avec
    5 % de benzocaïne

    *Individual results may vary
    *les resultants individuals prevent varier

    Wax / cire NET WT. 1.25 oz 35 g, Extrasoothe™ Lotion / lotion 0.5 fl oz 14.7 ml,
    Brow Guides / guides pour les sourcils, Temperature Indicator Applicator . applicateur avec indicateur
    de temperature, Mini Tweezers / mini pince à épiler, Orange Stick / bâtonnet orange, Instuctions

    Principal Display Panel – Kit Label
  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT 
    benzocaine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-155
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66184-155-011 in 1 CARTON01/01/2012
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 0.05 g
    Part 21 JAR 189.9 g
    Part 1 of 2
    SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT 
    benzocaine lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    IMIDUREA (UNII: M629807ATL)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    GERANIOL (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    EUGENOL (UNII: 3T8H1794QW)  
    CITRAL (UNII: T7EU0O9VPP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.05 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/01/2012
    Part 2 of 2
    SALLY HANSEN MICROWAVABLE EYBROW, FACE AND LIP WAX KIT 
    depilatories strip
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWHITE WAX (UNII: 7G1J5DA97F)  
    INGRCALCIUM CARBONATE (UNII: H0G9379FGK)  
    INGRMAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRCANOLA OIL (UNII: 331KBJ17RK)  
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
    INGRCHAMOMILE (UNII: FGL3685T2X)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRD&C RED NO. 17 (UNII: ND733RX3JN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1189.9 g in 1 JAR; 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crystal Claire Cosmetics205493484manufacture(66184-155)