Label: 20/20 TOPICAL ANESTHETIC- benzocaine strip

  • NDC Code(s): 76484-948-24
  • Packager: Advanced Dental Anesthetics
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 8, 2012

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Benzocaine 20%

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  • Purpose

    Oral pain reliever

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  • Use

    Temporary relief of oral pain

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  • Warnings

    Consult a physician or qualified health care professional prior to using this product if you have any medical conditions, or if you are using any prescription drug.

    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.

    KEEP OUT OF REACH OF CHILDREN.

    This carrying case may present a choking hazard. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

    Stop use and ask doctor if

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

    Not for use by individuals under 12 years of age.

    Dosage: 1 strip, not more than 4 per day

    • Remove 1 strip from carrying case.
    • Place strip onto area of desired anesthesia
    • Allow strip to dissolve completely
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  • Other

    Storage conditions: 55° to 78° Fahrenheit in a dry place. Keep foil pouch for information. KEEP AWAY FROM LIGHT

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  • Inactive ingredients

    Hydroxypropyl Methyl Cellulose, Gylcerine, Peppermint Oil Flavor, Gum Arabic, Sodium Carboxy Methyl Cellulose, Sucralose, Polysorbate 80, Sodium Copper Chlorophyllin.

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Advanced
    DENTAL ANESTHETICS

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  • PRINCIPAL DISPLAY PANEL - 24 Strip Pouch Label

    Active Ingredient: Benzocaine 20%

    20/20
    Topical Anesthetic Strip

    24 STRIPS

    PRINCIPAL DISPLAY PANEL - 24 Strip Pouch Label
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  • INGREDIENTS AND APPEARANCE
    20/20   TOPICAL ANESTHETIC
    benzocaine strip
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76484-948
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSE 2208 (3 MPA.S) (UNII: 9H4L916OBU) 18.44 mg
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ACACIA (UNII: 5C5403N26O)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
    Product Characteristics
    Color GREEN (Light Green) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76484-948-24 1 in 1 POUCH
    1 24 in 1 CASE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part356 02/28/2012
    Labeler - Advanced Dental Anesthetics (969804223)
    Establishment
    Name Address ID/FEI Business Operations
    Atlas Operations Inc 946369055 MANUFACTURE, PACK, LABEL
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