Label: ORAL B INSTANT PAIN 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 May 28, 2010

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  • Active Ingredient

    Benzocaine 20%

    Purpose

    Oral anesthetic

  • Uses

    Temporarily relieves pain associated with the following mouth and gum irritations:

    • toothache
    • sore gums
    • canker sores
    • braces
    • minor dental procedures
    • dentures
  • Warnings

    Allergy Alert: do not use this pr9oduct if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other :caine" anesthetics.

  • When using this product

    • Avoid contact with eyes
    • Do not exceed recommended dosage
    • Do not use for more than 7 days unless directed by a doctor/dentist
  • Stop use and ask a doctor if:

    • sore mouth symptoms do not improve in 7 days
    • Irritation, pain or redness persist or worsens
    • Swelling, pain or fever develops
  • Directions:

    • Remove cap-, squeeze gel onto applicator
    • Adults and children 2 years of age and older, apply to the affected area 4 times per day or as directed by a doctor/dentist
    • Children under 2 years of age; consult a doctor/dentist
    For Denture wearers
    • Remove Dentures
    • Apply thin layer to affected area
    • Do not reinsert dental work until irritation is relieved
    • Rinse mouth well before reinserting dentures
  • Other information:

    • Store between 200 to 250 C (680 to 770 F) Do not refrigerate
    • Do not purcahse if package has been opened
  • Inactive Ingredients

    Benzyl alcohol, carbomer 974P, FD and C green 5, Flavor, glycerin, Methylparaben, Polyethylene glycol, PEG 400, PEG 600, Sodium Saccharin

  • Oral B Pain gel label

    MM27oral B tooth pain gel label

  • Oral B pain gel blister

    MM28oral B tooth pain gel blister

  • Oral B shipper label

    MM29Oral B shipper label

  • INGREDIENTS AND APPEARANCE
    ORAL B INSTANT PAIN RELIEF  
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48871-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) Benzocaine0.2 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    benzyl alcohol (UNII: LKG8494WBH)  
    Glycerin (UNII: PDC6A3C0OX)  
    methylparaben (UNII: A2I8C7HI9T)  
    Polyethylene glycol (UNII: 3WJQ0SDW1A)  
    Polyethylene glycol 400 (UNII: B697894SGQ)  
    Polyethylene Glycol 600 (UNII: NL4J9F21N9)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: K61870Z308)  
    Product Characteristics
    Colorgreen (FD and C Green 5) Score    
    ShapeSize
    FlavorMINT (Scope Original Mint Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48871-008-0112 in 1 BOX
    16 in 1 CARTON
    13 in 1 BLISTER PACK
    16 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33306/31/2010
    Labeler - Health-Tech, Inc. (084007889)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health-Tech, Inc.084007889manufacture
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