EB301AP PAIN RELIEF- menthol spray

EB301AP PAIN RELIEF by

Drug Labeling and Warnings

EB301AP PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by EMINENCE BIOTECH CORPORATION LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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

INGREDIENTS AND APPEARANCE

EB301AP PAIN RELIEF 
menthol spray

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	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	03/01/2013
1		100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 53304-0301-3	1 in 1 BOX	03/01/2013
2		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

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)