Label: ASSURED- lidocaine hydrochloride gel

  • NDC Code(s): 55621-010-01
  • Packager: Zhejiang Jingwei Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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  • INACTIVE INGREDIENT

    Inactive Ingredients  aloe barbadensis leaf juice, carbomer 940,

    glycerin, menthol, methylparaben, polyethylene glycol 400,

    propylene glycol, propylparaben, triethanolamine, water

  • ACTIVE INGREDIENT

    Active Ingredient

    Lidocaine hydrochloride 2.5 %

  • PURPOSE

    Purpose

    Topical analgesic

  • INDICATIONS & USAGE

    Uses  for temporary relief of pain associated with

    - minor burns

    - sunburn

    - minor cuts or scrapes

    - minor skin irritations

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    - in large quantities, particularly over raw surfaces

    or blistered areas

  • WHEN USING

    When using this product

    - avoid contact with eyes

  • STOP USE

    Stop use and ask a doctor if

    - if condition worsens, or if symptoms persist for more than 7 days

    or clear up and then occur again within a few days, discontinue use

    of this product and consult a physician

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help

    or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children under 2 years of age:

    - clean the affected area and gently dry

    - apply to the affected area not more than 3 to 4 times daily

    children udner 2 years of age: consult a physician

  • STORAGE AND HANDLING

    Other Information

    store at room temperature 59 - 86 F (15 C - 30 C )

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    ASSURED 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55621-010-011 in 1 BOX10/30/2014
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/30/2014
    Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-010)
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