Label: ANBESOL MAXIMUM STRENGTH- benzocaine gel

  • NDC Code(s): 80070-220-33
  • Packager: Foundation Consumer Brands
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzocaine 20%

  • Purpose

    Oral pain reliever

  • Uses

    • temporarily relieves pain associated with the following mouth and gum irritations:
      • toothache
      • sore gums
      • canker sores
      • braces
      • minor dental procedures
      • dentures
  • Warnings

    METHEMOGLOBINEMIA WARNING

    Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

    • pale, gray, or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    Allergy alert

    Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

    Do not use

    • for teething
    • in children under 2 years of age

    When using this product

    • avoid contact with the eyes
    • do not exceed recommended dosage
    • do not use for more than 7 days unless directed by a doctor/dentist

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness lasts or worsens
    • swelling, rash, or fever develops

    Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • to open tube, cut tip of the tube on score mark with scissors
      adults and children 2 years of age and overapply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist
      children between 2 and 12 years of age:should be supervised in the use of this product
      children under 2 years of agedo not use
    • for denture irritation:
      • apply thin layer to the affected area
      • do not reinsert dental work until irritation/pain is relieved
      • rinse mouth well before reinserting
  • Other information

    • store at 20-25°C (68-77°F)
    • do not refrigerate
  • Inactive ingredients

    benzyl alcohol, carbomer 934P, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin

  • Questions or comments?

    Call 1-888-594-0673 weekdays 9 AM to 5 PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by: Foundation Consumer Brands, LLC
    Pittsburgh, PA 15212

  • PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack

    MAXIMUM
    20%
    BENZOCAINE
    STRENGTH

    ANBESOL®
    ORAL PAIN RELIEVER |
    BENZOCAINE 20%

    INSTANT ORAL
    PAIN RELIEF

    ADA
    Accepted
    American
    Dental
    Association ®

    ✓
    TOOTHACHES
    ✓
    CANKER SORES
    ✓
    ALIGNER PAIN
    ✓
    GUM PAIN

    GEL

    NET WT 0.33 OZ (9 g)

    Principal Display Panel - 9 g Tube Blister Pack
  • INGREDIENTS AND APPEARANCE
    ANBESOL   MAXIMUM STRENGTH
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80070-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN (UNII: FST467XS7D)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80070-220-331 in 1 BLISTER PACK09/15/2021
    19 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35609/15/2021
    Labeler - Foundation Consumer Brands (117603632)
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