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Major Oral Pain Relief (Major Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
LIQUID 1 BOTTLE, GLASS in 1 BLISTER PACK (00904-5899-4) > 15 mL in 1 BOTTLE, GLASS (00904-5899-3) Label Information

Complete Major Oral Pain Relief Information

  • Active ingredient

    Benzocaine, 20%


  • Purpose

    Oral anesthetic


  • Uses

    Temporarily relieves pain associated with the following mouth and gum irritations:

    • toothache
    • sore gums
    • canker sores
    • braces
    • minor dental procedures
    • dentures

  • 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.


  • When using this product

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

  • Stop use and ask a doctor or dentist if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists 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 immediately

  • Directions

    • Adults and children 2 years of age and older:
    • wipe liquid on with cotton, or cotton swab, or finger tip.
    • apply to the affected area up to 4 times daily of as directed by a doctor or dentist.
    • Children under 12 years of age: adult supervision should be given in the use of this product.
    • Children under 2 years of age: consult a doctor or dentist.

  • Inactive ingredients

    Benzyl alcohol, D&C yellow #10, FD&C Blue #1, FD&C Red #40, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Saccharin


  • PRINCIPAL DISPLAY PANEL

    Major

    Oral Pain Relief

    Maximum Strength

    Liquid Oral Anesthetic

    0.5 FL OZ (15ml)

    label image

    image of label

    Major

    Oral Pain Relief

    Maximum Strength

    Liquid Oral Anesthetic

    0.5 FL OZ (15ml)

    card image

    image of card


  • INGREDIENTS AND APPEARANCE
    MAJOR ORAL PAIN RELIEF  MAXIMUM STRENGTH
    oral anesthetic liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:00904-5899
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN (UNII: FST467XS7D)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:00904-5899-4 1 in 1 BLISTER PACK
    1 NDC:00904-5899-3 15 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part356 08/01/2008
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    Name Address ID/FEI Business Operations
    Major Pharmaceuticals 191427277 label(00904-5899)
    Establishment
    Name Address ID/FEI Business Operations
    Lee Pharmaceuticals 056425432 pack(00904-5899)
    Establishment
    Name Address ID/FEI Business Operations
    Unipack 009248480 manufacture(00904-5899)