Label: ORAL PAIN RELIEF- oral pain reliever gel

  • 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 December 27, 2017

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  • Active ingredient (in each gram)

    Benzocaine 20%

  • Purpose

    Oral Pain Reliever

  • Uses

    for the temporary relief of pain due to

    • toothaches
    • canker sores
    • minor injury of the mouth and gums
    • minor irritation of the mouth and gums caused by 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

    Flammable: keep away from fire or flame. Avoid smoking during application and until this product has dried.

    Do not use

    more than directed for more than 7 days unless told to do so by a dentist or doctor

    Stop use and ask a doctor if

    swelling, rash or fever develops; irritation, pain or redness persists or worsens; symptoms do not improve in 7 days

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

  • Directions

    Directions cut open tip of tube

    Adults and children 2 years of age and overApply a small amount of product to the cavity and around gum surrounding the teeth. Use 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 ageAsk a dentist or doctor

  • Inactive ingredients

    Inactive ingredients flavor, glycerin, polyethylene glycol, sodium saccharin, sorbic acid,

  • Other Information

    • do not use if tube tip is cut prior to opening
    • this preparation is intended for use in case of toothache, only as a temporary expedient until a dentist can be consulted
    • do not use continuously


  • PRINCIPAL DISPLAY PANEL

    Discount Drug Mart Oral Pain Relief

    oral.carton

  • INGREDIENTS AND APPEARANCE
    ORAL PAIN RELIEF 
    oral pain reliever gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-996
    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
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-996-421 in 1 CARTON11/09/2015
    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 finalpart35611/09/2015
    Labeler - Discount Drug Mart, Inc. (047741335)
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