Label: MOUTH SORE RELIEF APPLICATOR- benzocaine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 14, 2013

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

View All Sections
  • Drug fact

    Active Ingredient

    Benzocaine 20%

  • Purpose

    Pain Reliever

  • Uses

    temporarily relieves these symptoms. cold sores. scanker sores. fever blisters. minor irritation or injury of the mouth and gums.

  • Warning 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 eye contact. do not exceed recommended dosage. do not use 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 worsen.

    Do not use on children under 2 years except underteh advice and supervision of a doctor.

  • Keep out of the reach of children

    if swallowed get medical help or contact a Poison Contro;mCenter right away.

  • Directions

    Snap the tip at the color ring. Allow formula to flow down to the opposite tip. Apply formula with the saturated tip to affected area

  • Other Information

    Avoid storaging at excessive heat.

  • Inactive Ingredient

    Polyethylene glycol 400 (PEG-8), Glycerin, Saccharin sodium, water, pina Colada

  • PRINCIPAL DISPLAY PANEL

    Image of carton label

    Image of mouth sore label

  • INGREDIENTS AND APPEARANCE
    MOUTH SORE RELIEF APPLICATOR 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-867
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65734-867-243.6 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/01/2005
    Labeler - Swabplus Inc. (876441549)
    Registrant - Swabplus Inc. (876441549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swabplus Inc.876441549manufacture(65734-867) , relabel(65734-867) , repack(65734-867)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!