EB301AP PAIN RELIEF- menthol spray 
EMINENCE BIOTECH CORPORATION LIMITED

Disclaimer: 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.

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EB301AP PAIN RELIEF

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 (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1000 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M)  
EUPHORBIA HIRTA (UNII: L13YF113GN)  
PORK SIDE BACON, CURED FAT (UNII: 6E710H379S)  
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
GLYCERIN (UNII: PDC6A3C0OX)  
EUPHORBIA THYMIFOLIA WHOLE (UNII: D56Y3D2OTL)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53304-0301-1 1 in 1 BOX
1 100 mL in 1 BOTTLE, SPRAY
2 NDC:53304-0301-3 1 in 1 BOX
2 15 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: 5/2013
Document Id: 46b38a46-4d28-4a88-aaec-ed23e9ff3f70
Set id: 3a5fe77f-c36a-41c0-ba86-0664b942e144
Version: 2
Effective Time: 20130530
 
EMINENCE BIOTECH CORPORATION LIMITED