Label: AMERICAINE- benzocaine ointment

  • NDC Code(s): 63736-375-01
  • Packager: Insight Pharmaceuticals LLC
  • Category: HUMAN OTC 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 January 14, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzocaine 20%

  • Purpose

    Hemorrhoidal Ointment

  • Uses

    temporarily relieves these symptoms associated with hemorrhoids

    • inflammation
    • itching
    • local pain
    • soreness
  • Warnings

    For external use only

    When using this product

    • certain persons can develop allergic reactions to ingredients in this product
    • do not put this product into the rectum by using fingers or any mechanical device or applicator
    • do not exceed dosage unless directed by a doctor

    Stop use and ask a doctor if

    • condition worsens or does not improve in 7 days
    • bleeding occurs
    • symptoms do not get better, or if redness, irritation, swelling, pain or other symptoms occur or increase

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults

    • when practical, cleanse affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.
    • apply externally to the affected area up to 6 times daily

    Children under 12 years: ask a doctor

  • Other information

    • if ointment contacts clothing or other fabrics, wash in warm water only; do not use bleach.
    • store at room temperature 15°– 25°C (59°– 77°F)
    • tube is sealed for your protection. Do not use if foil seal is broken or missing.
  • Inactive ingredients

    benzethonium chloride, polyethylene glycol 300, polyethylene glycol 3350.

  • QUESTIONS?

    Call 1-800-344-7239 or visit our website at www.insightpharma.com

    Distributed by: Insight Pharmaceuticals LLC

    Tarrytown, NY 10591

    A Prestige Brands Company 

  • PRINCIPAL DISPLAY PANEL:


    Americaine® 
    Benzocaine
    Hemorrhoidal Ointment

    NET WT. 1 OZ (28 G)

    PRINCIPAL DISPLAY PANEL: Americaine® Benzocaine Hemorrhoidal Ointment NET WT. 1 OZ (28 G)

  • INGREDIENTS AND APPEARANCE
    AMERICAINE 
    benzocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-375
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5.6 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    Product Characteristics
    ColorWHITE (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-375-011 in 1 BOX07/10/2009
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34607/10/2009
    Labeler - Insight Pharmaceuticals LLC (055665422)
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