RxNorm Names

Review RxNorm Normal Forms

EB301AP PAIN RELIEF (menthol) spray
[EMINENCE BIOTECH CORPORATION LIMITED]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3a5fe77f-c36a-41c0-ba86-0664b942e144

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

Menthol 1%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain

Warnings

For external use only

Do not use

on ears or nasal cavity
if pregnant
on wounds or damaged skin
otherwise than as directed

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

conditions worsen
symptoms persist for more than 7 days, or symptoms clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over

Spray sufficient amount onto affected area to cover it completely, and rub until dry. Repeat no more than 3 to 4 times daily.

Children under 12 years of age

consult a doctor.

Other information

Store at cool place (room temperature) away from heat and light sources.

Inactive ingredients

Alcohol, Animal Fat, Euphorbia Hirta, Euphorbia Thymifolia Whole, Gaultheria Procumbens (Wintergreen) leaf Extract, Glycerin, Water

Questions?

Call 1-562-207-8624

Distributed by:

EMINENCE BIOTECH CORPORATION LIMITED

3411 SILVERSIDE ROAD, RODNEY BUILDING # 104
WILMINGTON DE19810 NEW CASTLE COUNTY, USA

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

EB
Eminence
Biotech

EB301AP

PAIN RELIEVING SPRAY

3.38FL OZ (100mL)

NDC 53304-0301-1

Principal Display Panel - 100 mL Bottle Carton

EB301AP PAIN RELIEF
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53304-0301
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	1000 mg in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL
EUPHORBIA HIRTA
PORK SIDE BACON, CURED FAT
GAULTHERIA PROCUMBENS LEAF
GLYCERIN
EUPHORBIA THYMIFOLIA WHOLE
WATER

Packaging
#	Item Code	Package Description
1	NDC:53304-0301-1	1 in 1 BOX
1		100 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2013

Labeler - EMINENCE BIOTECH CORPORATION LIMITED (078531141)

Revised: 02/2013

Document Id: 9d9f2f48-b04b-4910-b47d-659cbf373fd7

Set id: 3a5fe77f-c36a-41c0-ba86-0664b942e144

Version: 1

Effective Time: 20130228