Label: BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC- lidocaine cream

  • Category: HUMAN PRESCRIPTION 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 March 9, 2012

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  • Drug Facts

    Active Ingredients

    Lidocaine 4%

  • Purpose

    Local Analgesic

  • Uses

    For the temporary relief of pain and itching due to:

    ■ minor burns

    ■ minor skin irritations

    ■ scrapes

    ■ minor cuts

    ■ sunburn

    ■ insect bites

  • Warnings

    For external use only

    When using this product

    ■ avoid contact with the eyes

    ■ do not use in large quantities, particularly over raw surfaces or blistered areas

  • Stop use and ask doctor if:

    ■ condition worsens

    ■ symptoms persist for more than 7 days

    ■ symptoms clear up and occur again within a few days

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.

    ■ Children under 2 years of age: Consult a doctor.

  • Inactive Ingredients

    Aloe, Water, Cholesterol, Isopropyl Myristate, Aqua Caprylic/Capric Triglyceride, Propylene Glycol, Hydrogenated Phosphatidylcholine, Glyceryl Stearate, PEG-100 Stearate, Arginine HCL, Ethyl Oleate, Propylene Glycol, Tocophersolan, Cetyl Alcohol, Triethanolamine, Xanthan Gum, Tocopherol, Allantoin, Aloe Barbadensis Leaf, Methylisothiazolinone, Methyl Nicotinate.

  • Package and Label Images

    Lidum 4 Label

    Lidum 4 Box

    Lidum 4 Unit Pak Label

    Lidum 4 Unit Pak Box

  • INGREDIENTS AND APPEARANCE
    BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC 
    lidocaine cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60608-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2.8 g  in 56 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TOCOPHERSOLAN (UNII: O03S90U1F2)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    xanthan gum (UNII: TTV12P4NEE)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALLANTOIN (UNII: 344S277G0Z)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYL NICOTINATE (UNII: 7B1AVU9DJN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60608-017-011 in 1 BOX
    1NDC:60608-017-0056 g in 1 TUBE
    2NDC:60608-017-0315 in 1 BOX
    2NDC:60608-017-024.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/07/2012
    Labeler - Bio-Scriptives, Inc. (802946426)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coastal Products Company782445688manufacture
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