Label: ATOPALM ORAL 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 February 6, 2012

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  • Active Ingredient

    Benzocaine 10%

    Purpose

    Oral Pain Reliever

  • Use

    for the temporary relief of pain due to toothaches.

  • 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

    Do not use

    • more than directed
    • for more than 7 days unless told to do so by a dentist or a 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.

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

  • Directions

    • cut open tip of tube at 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 a 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 a doctor.
  • Other information

    • 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 can be consulted. Do not use continuously.
  • Inactive Ingredients

    PEG-400, PEG-6000, Glycerin, Sodium Saccharin, Sorbic Acid, Flavor

  • Questions or information?

    Call toll free 1-855 ATOPALM – (1-855-286-7256)

  • Labeling Information

    ATOPALM Oral Pain Relief Gel

    Fast Temporary Relief of Pain Due to Toothache

    Benzocaine 10%


    Distributed by: NeoPharm USA, 1 Oyster Bay Drive, Rumson, NJ 07760
    Made in Korea




    Atopalm Oral Gel



    Atopalm Oral Gel

  • INGREDIENTS AND APPEARANCE
    ATOPALM ORAL PAIN RELIEF 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0236
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-0236-71 in 1 BOX
    17 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/06/2012
    Labeler - NeoPharm, USA (965502912)
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