Label: SHEFFIELD PAIN RELIEF- benzocaine gel 

  • Label RSS
  • NDC Code(s): 11527-062-55
  • Packager: Faria LLC dba Sheffield Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active Ingredient

    Benzocaine 20%

    Close
  • Purpose

    Oral Pain Reliever

    Close
  • Uses

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

    Close
  • 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
    Close
  • Other information

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

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

    Close
  • Principal Display Panel – 0.33oz Carton Label

    NDC 11527-062-47

    Oral Pain Relief

    MAXIMUM STRENGTH GEL

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

    Dr. Sheffield's

    SHEAF-FIELD

    Made in the USA

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

    NDC 11527-062-47

    Oral Pain Relief

    MAXIMUM STRENGTH GEL

    Benzocaine 20%

    Dr. Sheffield's

    SHEAF-FIELD

    Made in the USA

    The Adult Medicine for Toothache

    Fast Toothache Pain Reliever

    NET WT. 0.33 OZ (9.35g)

    Principal Display Panel – 0.33oz Tube Label
    Close
  • INGREDIENTS AND APPEARANCE
    SHEFFIELD PAIN RELIEF 
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11527-062
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 300  
    POLYETHYLENE GLYCOL 400  
    POLYETHYLENE GLYCOL 1500  
    POLYETHYLENE GLYCOL 3350  
    Saccharin Sodium  
    Sorbic Acid  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor SPEARMINT (SPEARMINT) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11527-062-55 1 in 1 CARTON
    1 9.35 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 01/30/2006
    Labeler - Faria LLC dba Sheffield Pharmaceuticals (151177797)
    Establishment
    Name Address ID/FEI Business Operations
    Faria LLC dba Sheffield Pharmaceuticals 151177797 MANUFACTURE(11527-062)
    Close