Label: BENZOCAINE- benzocaine swab 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/14

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  • Active Ingredient

    Active Ingredient  Purpose  

    Benzocaine, 6% w/v                       Topical Analgesic


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  • Purpose for Benzocaine

    • For temporary relief of pain and itching associated with minor burns, sunburn, scrapes and insect bites or minor skin irritations
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  • Keep Out of Reach of Children

    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center.
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  • Indications and Usage

    • For temporary relief of pain and itching associated with minor burns, sunburn, scrapes and insect bites or minor skin irritations.
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  • Warnings

    Warnings: Benzocaine

    • For external use only.
    • Flammable, keep away from fire or flame.

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  • Dosage

    Directions:

    • For adults and children 2 years of age and older, apply to affected area not more than 3-4 times daily.
    • Children under 2 years; consult a physician.

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  • Inactive Ingredients

    • Inactive Ingredients: Isopropyl Alcohol, Water.
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  • DO Not Use

    Do not use:

    With electrocautery procedures.

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  • Stop Use

    Stop use:

    If irritation and redness develop.
    If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

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  • Storage and Handling

    • Avoid excessive heat.
    • Store at room temperature: 15 - 30 degrees C (59 - 86 degrees F)
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  • Principal Display Panel

    Dynarex Sting and Bite

    Benzocaine.jpg

    Benzocaine

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  • INGREDIENTS AND APPEARANCE
    BENZOCAINE 
    benzocaine swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67777-246
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 60 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL ALCOHOL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67777-246-01 3000 in 1 CASE
    1 2 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 07/20/2011
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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