Your browser does not support JavaScript! SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]
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RxNorm Names

SHEFFIELD PAIN RELIEF (benzocaine) gel
[Faria LLC dba Sheffield Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

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

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11527-062
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 300 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 1500 
POLYETHYLENE GLYCOL 3350 
Saccharin Sodium 
Sorbic Acid 
Product Characteristics
Color    Score    
ShapeSize
FlavorSPEARMINT (SPEARMINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-062-551 in 1 CARTON
19.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/30/2006
Labeler - Faria LLC dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Faria LLC dba Sheffield Pharmaceuticals151177797MANUFACTURE(11527-062)

Revised: 1/2013
 
Faria LLC dba Sheffield Pharmaceuticals

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