Label: SHEFFIELD PAIN RELIEF- benzocaine gel

  • NDC Code(s): 11527-062-55
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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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

    Flavor, PEG 540, PEG 6, PEG 75, PEG 8, Sodium Saccharin, Sorbic Acid

  • Principal Display Panel – 0.33oz Carton Label

    Sheffield Pharmaceuticals             NDC 11527-062-47

    Oral Pain Relief

    Maxium Strength GEL

    Fast Toothache Pain Reliever

    20% Benzocaine Topical Gel 

    NET WT. 0.33 OZ (9.35g)

    Made in the USA

    Principal Display Panel – 0.33oz Carton Label

  • Principal Display Panel – 0.33oz Tube Label

     Sheffield Pharmaceuticals                                                           NDC 11527-062-47

    Oral Pain Relief

    Maxium Strength GEL

    Fast Toothache Pain Reliever 

    20 % Benzocaine Topical Gel 

    Made in the USA

    NET WT. 0.33 OZ (9.35g)

    Principal Display Panel – 0.33oz Tube Label

  • INGREDIENTS AND APPEARANCE
    SHEFFIELD PAIN RELIEF 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-062
    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)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbic Acid (UNII: X045WJ989B)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINT (SPEARMINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-062-551 in 1 CARTON01/30/2006
    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 DrugM02201/30/2006
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-062)
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