RED CROSS CANKER SORE (BENZOCAINE) OINTMENT [THE MENTHOLATUM COMPANY]

RED CROSS CANKER SORE (BENZOCAINE) OINTMENT [THE MENTHOLATUM COMPANY]
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NDC 10742-8915-1
Set ID 54cfff96-6665-4b36-a15d-10bf6cf3a1f9
Category HUMAN OTC DRUG LABEL
Packager The Mentholatum Company
Generic Name
Product Class
Product Number
Application Number PART356
  • Active ingredient

    Benzocaine 20%

  • Purpose

    Oral anesthetic/analgesic

  • Uses

    temporarily relieves pain and minor irritation of the mouth and gums due to ▪ canker sores ▪ minor dental procedures ▪ braces ▪ dentures

  • Warnings

    Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: ▪ pale, gray, or blue colored skin (cyanosis) ▪ headache ▪ rapid heart rate ▪ shortness of breath ▪ dizziness or lightheadedness ▪ fatigue or lack of energy

    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

    Do Not Use

    for teething
    in children under 2 years of age

    When using this product

    do not use for more than 7 days unless directed by a dentist or doctor
    do not exceed recommended dosage

    Stop use and ask a doctor if

    sore mouth symptoms last more than 7 days
    irritation, pain, or redness persists or worsens
    swelling, rash, or fever develops
  • Keep Out of Reach of Children

    If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    snip off tip of tube
    apply to affected area; carefully coat with a protective layer
    supervise children using this product
    adults and children 2 years and over: use up to 4 times daily or as directed by a doctor
    children under 2 years: do not use
  • Inactive Ingredients

    aloe barbadensis leaf extract, butylated hydroxytoluene, carbomer hompolymer, cetylpyridinium chloride, chamomilla recutita (matricaria) flower extract, cocos nucifera (coconut) oil, commiphora myrrha resin, dimethicone, echinacea purpurea extract, flavor, glyceryl stearate, menthol, mineral oil, silica dimethicone silylate, vitamin E, white petrolatum

  • Package/Label Principal Display Panel

    Red Cross Canker Sore Oral Anesthetic/Analgesic
  • Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    RED CROSS CANKER SORE 
    benzocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8915
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CHAMOMILE (UNII: FGL3685T2X)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MYRRH (UNII: JC71GJ1F3L)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8915-11 in 1 BLISTER PACK08/19/1998
    17 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 finalpart35608/19/1998
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757MANUFACTURE(10742-8915)

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