Label: RED CROSS CANKER SORE- benzocaine ointment

  • NDC Code(s): 10742-8915-1
  • Packager: The Mentholatum Company
  • 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 February 7, 2023

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  • 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)