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Quality Choice Maximum Strength Oral Pain Relieving (Chain Drug Marketing Association Inc)

Available Formats

Dosage Form Package Information Links
GEL 1 TUBE in 1 CARTON (63868-953-11) > 11.76 g in 1 TUBE Label Information

Complete Quality Choice Maximum Strength Oral Pain Relieving Information

  • ACTIVE INGREDIENT

    Active ingredient (each gram contains)                                                       Purpose

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


  • PURPOSE

    Uses temporarily relieves pain due to:

    • toothache
    • canker sores
    • cold sores
    • fever blisters
    • minor irritation of the mouth and gums caused by dentures or orthodontic appliances

  • WARNINGS

    Warnings Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, bensocaine or other "caine" anesthetics.


  • WHEN USING

    When using this product

    • do not use more than directed
    • do not use for more than 7 days unless directed by a doctor/dentist
    • do not use more than 4 times in a 24 hour period unless directed by a doctor/dentist

  • STOP USE

    Stop use and ask a doctor 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

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


  • INDICATIONS & USAGE

    Directions

    • remove cap and apply small amount of Oral Pain Relieving Gel to the cavity and around gum surrounding the teeth
    • adults and children 2 years of age and older: apply to the affected area up to 4 times daily or as directed by a doctor/dentist
    • children under 12 years of age: should be supervised in the use of this product
    • children under 2 years of age: ask a doctor/dentist
    • For denture Irritation:
    • apply thin layer to the affected area
    • do not reinsert denture work until irritation/pain is relieved
    • rinse mouth well before reinserting

  • STORAGE AND HANDLING

    Other information

    • store at 15° to 25°C (59° to 77°F)
    • Lot No. and Exp. Date: See box or crimp of tube

  • INACTIVE INGREDIENT

    Inactive ingredients flavor, polyethylene glycols, sodium saccharin, sorbic acid


  • DOSAGE & ADMINISTRATION

    Distributed By Quality Choice

    Novi, MI 48376-0995

    Made in Korea


  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING 
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-953
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63868-953-11 1 in 1 CARTON
    1 11.76 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 05/31/2013
    Labeler - Chain Drug Marketing Association Inc (011920774)