Label: BIO-SCRIPTIVES LIDUM- lidocaine cream

  • 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 June 3, 2011

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  • Active Ingredient

    Lidocaine 5%



  • Purpose

    Topical Anesthetic
  • Uses

    ■  rapid onset
    ■  temporary relief of pain and itching due to
    ■  minor burns
    ■  skin irritations
    ■  scrapes
    ■  cuts
    ■  sunburn
    ■  insect bites
  • Warnings

    For external use only.

    Do Not Use

    ■  in or near eyes
    ■  in large quantities, particularly over raw surfaces or blistered areas

    Stop use if

    ■  allergic reaction occurs
    ■  condition worses or does not improve within 7 days

    Keep out of the reach of children.

  • Directions

    ■  adults and children 2 years and up apply externally to affected areas 3-4 times a day.
  • Inactive Ingredients

    Aloe Vera Juice, Water, Cholesterol, lsopropyl Myristate, Aqua and Caprylic Capric Triglyceride and Propylene Glycol and Hydrogenated Phosphatitylcholine, Glyceryl Stearate and PEG-100 Stearate, Arginine HCI, Ethyl OLeate, Propylene Glycol, dAlpha-Tocopheryl Polyethylene Glycol-1000 Succinate, Cetyl Alcohol,  Triethanolamine, Xanthan Gum, Vitamin E, Allantoin, Aloe Vera Powder, Methylisothiazolinone, Methyl Nicotinate

  • Labels

    LidumFront

    LidumBack1

    LidumBack2

  • INGREDIENTS AND APPEARANCE
    BIO-SCRIPTIVES LIDUM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60608-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride2.8 g  in 56 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    TOCOPHERSOLAN (UNII: O03S90U1F2)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYL NICOTINATE (UNII: 7B1AVU9DJN)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60608-011-0056 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/23/2010
    Labeler - BioChemics, Inc (802946426)
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