Label: ASSURED BIKINI SMOOTH CREAM- lidocaine cream

  • NDC Code(s): 55621-011-01
  • Packager: Zhejiang Jingwei Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 25, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Lidocaine 2.00 %

  • PURPOSE

    Purpose

    Topical analgesic

  • INDICATIONS & USAGE

       temporarily relieves pain, itching and irritation. Uses

  • WARNINGS

    Warnings

    . For external use only

  • DO NOT USE

    Do not use

    -before any hair removal process that involves heat or lasers

    -in large quantities, particularly over raw surfaces or

    blistered areas

  • WHEN USING

    When using this product

    -avoid contact with eyes   -use only as directed

  • STOP USE

    Stop use and ask a doctor if

    -symptoms persist for more than 7 days or clear up and occur

    again within a few days

    -condition worsens

    -redness is present

    -irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    . In case of accidental ingestion, get Keep out of reach of children

    medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children over 12 years of age:

    -immediately after hair removal, apply sparingly and only to the

    areas where it is needed

    -Repeat as necessary, but no more than 4 times daily

    -Continue to apply as a regular part of your hair removal routine,

    whether you use a razor, wax or depilatory

  • STORAGE AND HANDLING

       store at room temperature 59 - 86 F Other information

    (15 - 30 C)

  • INACTIVE INGREDIENT

      aloe barbadensis leaf juice, carbomer Inactive Ingredients

    940, ethyl alcohol, ethylparaben, glycerin, menthol, propanediol,

    triethanolamine, water

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    ASSURED   BIKINI SMOOTH CREAM
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MALONDIALDEHYDE (UNII: 4Y8F71G49Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55621-011-011 in 1 BOX10/30/2015
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01510/30/2015
    Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
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