Label: DENTARIN- benzocaine 20% solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 27, 2024

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  • Active Ingredients:

    Active Ingredients: Purpose

    Benzocaine 20%............................... Oral Pain Reliever

  • Uses:

    Uses: Temporarily relieves pain caused by toothache, canker, sores, cold sores, fever blisters, minor irritation or injury of the moth and gums.

  • Warnings: Methemoglobinemia warning:

    Warnings: Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condiiton tha tmust 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 pal, gray, or blue colored skin cyanosis), headache, rapid heartbeat, shortness of breath, diziness or lightheadedness, fatigue or lack of enerygy. Keep away from eyes.

  • Allergy alert

    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. If a skin reaction occurs, stop use and seek medical attention right away.

  • Flammability warning

    Flammability warning: keep away from fire or flame

  • Do not use

    Do not use: more than directed, for more than 7 days unless told to do so by a dentist or doctor, for teething, in children under 2 years of age.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if: sore mouth symptoms do not improve in 7 days, swelling, rash or fever develops, pain or redness persists or worsens.

  • If pregnant or breastfeeding

    If pregnant or breastfeeding, ask a health professional before use

  • Keep out of reach of children

    keep out of rech of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions:

    Adults and children 2 years of age older | Apply to affected area up to 4 times daily or as directed by dentist or doctor
    Children under 12 years of age | Should be supervised in the use of this product
    Children under 2 years of age | Do not use

    Directions: Spray a small amount of product around the affected area up to 4 times daily.

  • Other information

    Other information: Store at controlled room temperature: 15-30ºC (59-86ºF). Tamper Evident Feature: Do not use if cello-band over cap is torn, broken or missing.

  • Inactive ingredients

    Inactive ingredients: alcohol, clove oil, glycerin, polyethylene glycol, propylene glycol, sodium methylparaben, sodium saccharin

  • Doseage and administration

    Adults and children 2 years of age older | Apply to affected area up to 4 times daily or as directed by dentist or doctor
    Children under 12 years of age | Should be supervised in the use of this product
    Children under 2 years of age | Do not use

    Directions: Spray a small amount of product around the affected area up to 4 times daily.

  • Dentarin

    Dentarin

    Balsamo Dental En Spray

    Helps relieve Toothache and Mouth Sores

    Net Contents: 1 Fl. Oz (30mL)

    Dentarin Label

  • INGREDIENTS AND APPEARANCE
    DENTARIN 
    benzocaine 20% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69469-200
    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
    CLOVE OIL (UNII: 578389D6D0)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69469-200-3030 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02208/01/2024
    Labeler - Vitamex USA, Corp. (054256676)