Label: PM TOOTHACHE RELIEF- benzocaine paste

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

Drug Label Information

Updated February 22, 2024

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    For the temporary relief of pain due to toothaches. To help protect aganist infection of minor oral irritation.

  • INACTIVE INGREDIENT

    ammonium glycyrrhizate, chamomile, flavor, mineral oil, PEG-8, PEG-77, sodium saccharin, sorbic acid, titanium dioxide

  • INDICATIONS & USAGE

    Cut open tip of tube on score mark. Adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product. Children under 2 years of age: do not use.

  • ACTIVE INGREDIENT

    Belzalkomium Chloride 0.13% Oral antiseptic

    Benzocaine 20% Oral pain releiver

    Methol 0.26% Oral pain releiver

    Zinc chloride 0.15% Oral astringent

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a POison Control Center right away.

  • PURPOSE

    Do not nuse if tube tip is cust prior to opening. This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously . This formula will stay in place for extended duration of relief. Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying.

  • WARNINGS

    Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition tha tmust be treated promptly becuase 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.

  • PRINCIPAL DISPLAY PANEL

    20% benzocaine to releive oral pain

    Kills harmful bacteria

    Astringent to help prevent infection

    Cools gums and relieves irritation

    Net Wt 0.25 oz (7g)

    PDP

  • INGREDIENTS AND APPEARANCE
    PM TOOTHACHE RELIEF 
    benzocaine paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1623
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.26 g  in 100 g
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.15 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SORBIC ACID (UNII: X045WJ989B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorwhite (cloudy white to yellow) Score    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1623-091 in 1 BOX10/28/2022
    17.1 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/27/2022
    Labeler - Walgreens (008965063)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(0363-1623) , pack(0363-1623)