Label: LIDOCAINE 5%- lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

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  • ACTIVE INGREDIENT

    Lidocaine 5% w/w

  • PURPOSE

    Local Anesthetic

    Uses Temporarily relieves pain and itching due to anorectal disorders

  • WARNINGS

    When using this product

    • Avoid contact with eyes
    • Do not exceed recommended dosage unless directed by a doctor
  • ASK DOCTOR

    • Rectal bleeding occurs
    • Condition worsens or does not improve within 7 days
    • Allergic reaction occurs
    • Redness, irritation, swelling, pain or other symptoms begin or increase
    • Symptoms clear up and return within a few days
  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    • When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
    • Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
    • Children under 12 years of age: Consult a doctor
  • OTHER SAFETY INFORMATION

    Store at room temperature 20-25°C (68-77°F); Excursions permitted 15-30°C (59-86°F) [see USP Controlled Room Temperature].

  • INACTIVE INGREDIENT

    Benzyl Alcohol, Carbopol 940 (Carbomer 940), Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate (Alpha Tocophferol Acetate)

  • DOSAGE

    50 miligrams/gram per application

  • USAGE

    Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
    Children under 12 years of age: Consult a doctor

  • PRINCIPAL DISPLAY PANEL

    NDC 24689-124-01

    Lidocaine 5% Anorectal Cream

    Apnar Pharma LP

    Net.Wt 30 grams

    Lidocaine cream caron

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 5% 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-124
    Route of AdministrationRECTAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-124-011 in 1 CARTON11/01/2021
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01511/01/2021
    Labeler - Apnar Pharma LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Invaderm078610697analysis(24689-124) , manufacture(24689-124) , pack(24689-124)
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