Label: LIDOCAINE 5%- 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 October 22, 2021

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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 finalpart34611/01/2021
    Labeler - Apnar Pharma LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Invaderm078610697analysis(24689-124) , manufacture(24689-124) , pack(24689-124)