CAINETIPS (BENZOCAINE) LIQUID [J MORITA USA INC]

CAINETIPS (BENZOCAINE) LIQUID [J MORITA USA INC]
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NDC 70769-101-11, 70769-101-51
Set ID 0b5b73cc-5c43-49a8-9e36-a23391f766df
Category HUMAN OTC DRUG LABEL
Packager J MORITA USA INC
Generic Name
Product Class
Product Number
Application Number PART348
  • 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)

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