SHEFFIELD PAIN RELIEF- benzocaine gel 
Sheffield Pharmaceuticals LLC

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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

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

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)

Revised: 11/2023
Document Id: fbb18ede-0cb2-4a87-bffd-70abd04d8155
Set id: e21abfdd-373d-42af-9535-fe1571382a65
Version: 4
Effective Time: 20231128
 
Sheffield Pharmaceuticals LLC