RED CROSS ORAL PAIN RELIEF (BENZOCAINE) LIQUID [THE MENTHOLATUM COMPANY]

RED CROSS ORAL PAIN RELIEF (BENZOCAINE) LIQUID [THE MENTHOLATUM COMPANY]
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NDC 10742-8902-1
Set ID cbd41429-f730-4577-9f06-ef1831cf62e1
Category HUMAN OTC DRUG LABEL
Packager The Mentholatum Company
Generic Name
Product Class
Product Number
Application Number PART356
  • Active ingredient

    Benzocaine 20%

  • Purpose

    Oral pain reliever

  • Uses

    temporarily relieves pain associated with ▪ toothache ▪ canker sores ▪ minor mouth irritation or injury of the mouth and gums caused by dentures or braces

  • 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 do not improve in 7 days
    swelling, rash, or fever develops
    irritation, pain, or redness persists or worsens
  • 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

    using tweezers, immerse cotton pellet in medication
    apply pellet to affected area, then remove
    adults and children 2 years and over: use up to 4 times daily or as directed by a dentist or doctor
    children under 12 years: supervise while using this product
    children under 2 years: do not use
  • Inactive Ingredients

    ammonium glycyrrhizate, flavor, polyethylene glycol, propylene glycol, saccharin calcium

  • Package/Label Principal Display Panel

    Red Cross Oral Pail Oral Anesthetic
  • Principal Display Panel

    Drug Facts

  • INGREDIENTS AND APPEARANCE
    RED CROSS ORAL PAIN RELIEF 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN CALCIUM (UNII: 5101OP7P2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8902-11 in 1 BLISTER PACK06/01/2013
    13.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/01/2013
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757MANUFACTURE(10742-8902)

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