Label: CAINETIPS- benzocaine liquid

  • NDC Code(s): 70769-101-11, 70769-101-51
  • Packager: J MORITA USA INC
  • 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 September 22, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    BENZOCAINE 20%

  • PURPOSE

    PAIN RELIEVER

  • USES

    For temporary relief of pain due to: minor dental procedures, minor mouth and/or gum irritation caused by dentures or orthodontic appliances, Vincent's infection, or canker sores.

  • WARNINGS

    Do not use: if patient is allergic to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics;
    exceeding recommended dosage for more than 7 days unless directed by a dentist; if sore mouth symptoms
    do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see a
    dentist or a physician promptly.

  • PREGNANCY

    If pregnant or breast feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DIRECTIONS

    HOLD WITH SOLID WHITE TIP STRAIGHT DOWN; BEND AND SNAP OPEN UPPER TIP AT COLORED RING; ALLOW MEDICINE TO FLOW DOWN.

    APPLY PRODUCT TO INTENDED AREA; ALLOW IT TO REMAIN IN PLACE AT LEAST 1 MINUTE AND THEN REMOVE IT FROM MOUTH; DISPOSE AFTER APPLICATION.

    USE UP TO 4 TIMES DAILY, OR AS DIRECTED BY A DENTIST. ADULT SUPERVISION REQUIRED FOR USE WITH CHILDREN UNDER 12 YEARS. CONSULT A DENTAL PROFESSIONAL FOR USE WITH CHILDREN UNDER 2 YEARS.

  • INACTIVE INGREDIENTS

    ARTIFICIAL FLAVOR, POLYETHYLENE GLYCOL, ETHOXY DIGLYCOL

  • PRINCIPAL DISPLAY PANEL

    Canine Tips_Drug Facts Box

    Canine Tips_Product Image

    caninetips_ps_0809_v1

  • INGREDIENTS AND APPEARANCE
    CAINETIPS 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70769-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70769-101-51100 in 1 BOX06/06/2016
    1NDC:70769-101-110.15 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/06/2016
    Labeler - J MORITA USA INC (021866033)
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!