RxNorm Names

Review RxNorm Normal Forms

OPAHL (benzocaine) gel
[Dharma Research, inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a6e52905-8cbd-4cf3-8846-454b9633a13d

Category	DEA Schedule	Marketing Status
HUMAN PRESCRIPTION DRUG LABEL		unapproved drug other

NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.

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

Ingredients

Each gram of Opahl 20% benzocaine gel contains 200mg of benzocaine USP, in a water soluble base of PEG 3350, PEG 400, Flavor, Sodium Saccharine USP, Tocopheryl Acetate, Xylitol, FD&C Red #40, FD&C Yellow #5.

Usual Dosage

For oral mucosa. Use only as directed by a dentist

Warning

Keep out of reach of children. Store at controlled room temperature 59o to 86o F (15o - 30oC) Protect from freezing and heat.

Caution

Federal (USA) law prohibits dispensing without a prescription

Label

Entire Label

OPAHL
benzocaine gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:53045-103
Route of Administration	ORAL, TOPICAL, DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (BENZOCAINE)	BENZOCAINE	6.4 g in 32 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
SACCHARIN SODIUM
XYLITOL
.ALPHA.-TOCOPHEROL ACETATE, DL-

Product Characteristics
Color		Score
Shape		Size
Flavor	MANGO (Mango Frappe)	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:53045-103-30	32 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2013

Labeler - Dharma Research, inc. (078444642)

Registrant - Dharma Research, inc. (078444642)

Establishment
Name	Address	ID/FEI	Business Operations
Dharma Research, inc.		078444642	manufacture(53045-103)

Revised: 01/2013

Document Id: 37744207-cb84-4ab8-934c-7cc04d32371f

Set id: a6e52905-8cbd-4cf3-8846-454b9633a13d

Version: 1

Effective Time: 20130116

Dharma Research, inc.

Daily Med

Current Medication Information

Options

Additional Resources