Label: BIO-SCRIPTIVES LIDUM HEMORROIDAL (ANORECTAL)- 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 March 9, 2012

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  • Active Ingredient

    Lidocaine 5%

  • Purpose

    Local Anesthetic

  • Uses

    ■ For the temporary relief of local discomfort associated with anorectal disorders

    ■ For the temporary relief of pain, soreness, and burning.

  • Warnings

    For external use only.

    When using this product ■ do not exceed the recommended daily dosage unless directed by a doctor.

    do not put this product into the rectum by using fingers or any mechanical device or applicator.

  • Stop use and consult a doctor if:

    ■ condition worsens or does not improve within 7 days ■ bleeding occurs ■ allergic reaction occurs ■ redness, irritation, swelling, pain or other symptoms develop or increase

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    ■ Children under 12 years of age: consult a doctor. ■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply externally to the affected area up to 6 times daily.

  • Inactive Ingredients

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

  • Package and Lidum Images

    Lidum 5 Label

    Lidum 5 Box

    Lidum 5 Unit Pak Label+

    Lidum 5 Unit Pak Box

  • INGREDIENTS AND APPEARANCE
    BIO-SCRIPTIVES LIDUM HEMORROIDAL (ANORECTAL) 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60608-016
    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:60608-016-011 in 1 BOX
    1NDC:60608-016-0056 g in 1 TUBE
    2NDC:60608-016-0315 in 1 BOX
    2NDC:60608-016-024.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/04/2012
    Labeler - Bio-Scriptives, Inc. (802946426)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coastal Products Company782445688manufacture(60608-016)