Label: MEIJER MAXIMUM STRENGTH ORAL PAIN RELIEF- benzocaine, and benzalkonium chloride gel

  • 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 December 8, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                           Purpose

    Benzocaine 20%..............................Oral pain reliever

    Benzalkonium chloride 0.1%............Antiseptic

  • PURPOSE

    Use

    • for the temporary relief of pain due to toothaches
    • to help protect against infection in minor oral irritation
  • WARNINGS

    Warnings

    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

    Do not use

    • more than directed
    • for more than 7 days unless directed by a physician or healthcare provider
  • STOP USE

    Stop use and ask a physician if

    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens
    • symptoms do not improve in 7 days
    • allergic reaction occurs
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • cut open tip of tube on score mark
       Adults and children 2 years of age and over                                                                                                                               Apply a small amount of product to the cavity around gum surrounding the teeth.
       Children under 12 years of age Should be supervised in the use of this product
       Children under 2 years of age Ask a physician or healthcare provider
  • STORAGE AND HANDLING

    Other information

    • do not use if tube tip is cut prior to opening
    • this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
    • do not use continuously
    • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

  • DOSAGE & ADMINISTRATION

    DIST. BY MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MEIJER MAXIMUM STRENGTH ORAL PAIN RELIEF 
    benzocaine, and benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-782
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-782-421 in 1 BOX12/08/2016
    111.9 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 finalpart35612/08/2016
    Labeler - MEIJER DISTRIBUTION INC (006959555)