SHEFFIELD PAIN RELIEF- benzocaine gel 
Faria LLC dba Sheffield Pharmaceuticals

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.

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Drug Facts

Active Ingredient

Benzocaine 20%

Purpose

Oral Pain Reliever

Uses

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

Other information

Inactive ingredients

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

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

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
SHEFFIELD PAIN RELIEF 
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-062
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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     
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)

Revised: 1/2013
Document Id: 597b7ed5-3464-481a-ad76-7db05e91f5f5
Set id: e21abfdd-373d-42af-9535-fe1571382a65
Version: 1
Effective Time: 20130108
 
Faria LLC dba Sheffield Pharmaceuticals