Label: 7 SELECT ORAL PAIN MAXIMUM STRENGTH RELIEF- benzocaine gel

  • 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 December 8, 2016

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

  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

    Benzocaine 20%.................................Oral Pain reliever

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  • PURPOSE

    Use for the temporary relief of pain due to toothaches

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  • WARNINGS

    Warnings

    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

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  • DO NOT USE

    Do not use

    • more than directed
    • for more than 7 days unless directed by a dentist or doctor
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  • STOP USE

    Stop use and ask a 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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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

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  • INDICATIONS & USAGE

    Directions

    • remove cap and cut tip of tube on score mark
    • adults and children 2 years of age and older: apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor.
    • children under 12 years of age: should be supervised in the use of this product
    • children under 2 years of age: ask a dentist or doctor
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  • STORAGE AND HANDLING

    Other information

    • store at 15° to 25°C (59° to 77°F)
    • do not use if tube tip is cut prior to opening
    • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted
    • do not use continuously
    • lot no. & exp. date: see package or see crimp of tube
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  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, mint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

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  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY 7-ELEVEN, INC.

    Irving, TX 75063

    WWW.7-ELEVEN.COM

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    7 SELECT ORAL PAIN MAXIMUM STRENGTH RELIEF 
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-853
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINT (UNII: FV98Z8GITP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10202-853-14 1 in 1 BLISTER PACK 12/08/2016
    1 14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 12/08/2016
    Labeler - 7-ELEVEN, INC. (007347602)
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