Label: MOUTH SORE MEDICATION- benzocaine liquid

  • 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 June 23, 2014

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    COMPARE TO THE ACTIVE INGREDIENT IN KANK-A®

    ZEE MOUTH SORE MEDICATION

    ORAL PAIN RELIEVER

    Fast Mouth Sore Relief

    • Canker sores
    • Gum Pain
    • Toothache
    • Dental Work

    25 Packets

    0.5g (0.017 oz) per packet

    DO NOT USE IF PACKET IS TORN OR OPEN

    Drug Facts

  • Active ingredient

    Benzocaine 20% (w/w)

  • Purpose

    Oral pain reliever

  • Uses

    temporarily relieves pain caused by

    • toothache
    • canker sores
    • gum sores
    • dental work
    • cheek bites
    • denture irritation
    • minor irritation or injury of the mouth and gums
  • Warnings

    For oral use only. Avoid contact with eyes.

    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

    When using this product do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve e in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years and older: dry affected area and apply medication. Use up to 4 times daily, but not more than every 2 hours, 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: ask a dentist or doctor
  • Inactive ingredients

    PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

  • Questions?

    1-800-841-8417

    Distributed by
    Zee Medical, Inc., Irvine,CA 92606
    This product is not manufactured or distributed by Blistex, Inc., distributor of KANK-A® Mouth Pain Liquid

  • PRINCIPAL DISPLAY PANEL – packet label

    DO NOT USE IF PACKET IS TORN OR OPEN

    MOUTH SORE ZEE

    MEDICATION

    Oral Pain Reliever

    Fast Mouth Sore Relief

    • Canker sores
    • Gum Pain
    • Toothache
    • Dental Work

    5g (0.017 oz)

    PRINCIPAL DISPLAY PANEL – packet label
  • PRINCIPAL DISPLAY PANEL – Carton label

    NDC 35418-631-01

    COMPARE TO THE ACTIVE INGREDIENT IN KANK-A®*

    ZEE MOUTH SORE MEDICATION

    ORAL PAIN RELIEVER

    Fast Mouth Sore Relief

    • Canker sores
    • Gum Pain
    • Toothache
    • Dental Work

    25 Packets

    0.5g (0.017 oz) per packet

    PRINCIPAL DISPLAY PANEL – Carton label
  • INGREDIENTS AND APPEARANCE
    MOUTH SORE MEDICATION 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-631
    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 400 (UNII: B697894SGQ)  
    polyethylene glycol 3350 (UNII: G2M7P15E5P)  
    peppermint oil (UNII: AV092KU4JH)  
    saccharin sodium dihydrate (UNII: SB8ZUX40TY)  
    sorbic acid (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35418-631-0125 in 1 BOX
    10.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/01/2010
    Labeler - Zee Medical (009645623)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec Of America, Inc.874965262MANUFACTURE(35418-631)
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!