Label: EQUATE 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 August 18, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzocaine 20%

  • Purpose

    Oral Pain Reliever

  • Uses

    • temporary relief of occasional minor irritation, pain and sore mouth
  • 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 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

    • do not use tube if it is cut prior to opening
    • cut open tip of tube on score mark
    • use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
    • apply to affected area up to four times daily or as directed by a dentist or physician
    • Adults and children 2 years of age and older: Apply to affected area
    • Children under 12 years of age should be supervised in the use of this product
    • Children under 2 years of age: Consult a doctor
  • Other information

    • store at a controlled room temperature 59°-86°F (15°-30°C)
  • Inactive ingredients

    Benzyl Alcohol, Carboer, D&C Yellow No10, FD&C Blue No1, FD&C Red No40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin

  • Principal Display Panel – 0.33oz Carton Label

    NDC 11527-081-28

    Oral Pain Relief

    MAXIMUM STRENGTH GEL

    Benzocaine 20% NET WT. 0.33 OZ (9.35g)

    Principal Display Panel – 0.33oz Carton Label

    Principal Display Panel – 0.33oz Carton Label
  • Principal Display Panel – 0.33oz Tube Label

    NDC 11527-081-28

    Oral Pain Relief

    MAXIMUM STRENGTH GEL

    Benzocaine 20%

    The Adult Medicine for Toothache

    Fast Toothache Pain Reliever

    NET WT. 0.33 OZ (9.35g)

    Principal Display Panel – 0.33oz Tube Label

    Principal Display Panel – 0.33oz Tube Label
  • INGREDIENTS AND APPEARANCE
    EQUATE ORAL PAIN RELIEF 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-081
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 934 (UNII: Z135WT9208)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorSPEARMINT (SPEARMINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-081-281 in 1 CARTON01/23/200712/31/2023
    19.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/23/2007
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-081)
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