BABY SENSIGEL NIGHT TIME FORMULA (BENZOCAINE) GEL [DR. FRESH, INC]

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BABY SENSIGEL NIGHT TIME FORMULA (BENZOCAINE) GEL [DR. FRESH, INC]
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NDC 64893-384-02
Set ID 5a9e381d-a8c2-413e-bf25-92119cba6cfc
Category HUMAN OTC DRUG LABEL
Packager Dr. Fresh, Inc
Generic Name
Product Class
Product Number
Application Number PART356
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  • Active Ingredient

    Benzocaine 10%

  • Purpose

    Oral Pain Reliever

  • Use

    for the temporary relief of pain due to toothaches.

  • Warnings

    For external use only.

    Allergy Alert: do not use the product if you havd a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

    Do not use

    for more than 7 days unless recommended by a dentist or doctor.

    Stop use and ask a doctor if

    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

    Wash hands - remove pen cap - twist the bottom several times until the brush tip is covered with the gel.

    Adults and children 6 years of age and older: Apply a small amount of product to the cavity and around the 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 6 years of age:  Ask a dentist or doctor.

  • Other Information

    Do not use if pen or package  has been opened. This preparation is intended for use in case of toothache, only as a temporary expedient until a dentist can b consulted. Do not use continuously. This formula will stay in place for an extended duration for relief.

  • Inactive Ingredients

    Flavor, Glycerin, Polyethylene Glycol, Polyvinyl Pyrrolidone, Sorbic Acid, Sucralose

  • DESCRIPTION

    SensiGel, Baby SensiGel and related trademarks, names, logos, and patents are the property of Dr. Fresh, Inc, and are registered and/or used in the U.S. and countries around the world.

    (c)2011  Dr. Fresh, Inc.

    Distributed by:

    Dr. Fresh Inc.
    Buena Park, CA 90620 USA

    Canada  - Dr. Fresh, Inc.
    Ontario, Canada L7C2T4

    U.K. Grosvenor Consumer products Limited (Dr. Fresh, UK)
    268 Bath Road Slough Berkshire SL 1 4DX  


    Questions? Comments?
    Toll Free: 1-866-373-7374
    USA: +1-714-690-1573
    UK AND IRL: +44(0) 1753 725365

    comments@drfresh.com

    visit us online at:
    www.drfresh.com
    www.drfesh.uk


  • Product Label

    SensiGel label

  • INGREDIENTS AND APPEARANCE
    BABY SENSIGEL NIGHT TIME FORMULA 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-384
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SORBIC ACID (UNII: X045WJ989B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64893-384-022 g in 1 PACKAGE; Type 0: Not a Combination Product10/07/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/07/2011
    Labeler - Dr. Fresh, Inc (078508990)
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