RxNorm Names

Review RxNorm Normal Forms

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

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e21abfdd-373d-42af-9535-fe1571382a65

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

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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 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 (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
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: 01/2013

Document Id: 597b7ed5-3464-481a-ad76-7db05e91f5f5

Set id: e21abfdd-373d-42af-9535-fe1571382a65

Version: 1

Effective Time: 20130108

Faria LLC dba Sheffield Pharmaceuticals

Daily Med

Current Medication Information

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