THE MEDICINE SHOPPE EXTRA STRENGTH PAIN RELIEVING- menthol gel

The Medicine Shoppe Extra Strength Pain Relieving by

Drug Labeling and Warnings

The Medicine Shoppe Extra Strength Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Medicine Shoppe International Inc, Span Packaging Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 3.5%.......................

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis backache strains sprains

Warnings:

For external use only

Ask a doctor before use if you have:

sensitive skin, are pregnant or breast feeding

When Using This Product:

Avoid contact with eyes or mucous membranes  Do not apply to wounds, damaged or irritated skin, or excessive irritation develops  Do not bandage or use with heating pad or device, ointments, creams, sprays, liniments  Wash hands after with cool water

Stop Use And Ask A Doctor If:

Conditions worsens, symptoms persist more than 7 days, or clear up and recur

Keep out of reach of children:

If ingested, get medical help. Contact Poison Control Center immediately.

Directions:

Adults / children 2 years and older: Massage onto affected area up to 4 times daily  Children under 2 years of age: Consult Physician

Other Information:

Store cool dry place, lid closed tightly. Keep away from excessive heat or open flame

Inactive Ingredients:

Water, isopropyl alcohol, herbal extract (IIex paraguariensis), menthol, carbomer, triethanolamine, silicon dioxide, methylparaben, glycerine, propylene glycol, FDandC blue #1

Description

0  91899 41226  5  LOT  Distributed By: Medicine Shoppe International, Inc.  St. Louis, MO 63132  A Cardinal Health Company  CIN 1679646  The Medicine Shoppe Guarantee if you are not fully satisfied with this product, simply return the unused portion for replacement of full refund of purchase price.  100%  GUARANTEED SATISFACTION

PRINCIPAL DISPLAY PANEL

The Medicine Shoppe EXTRA STRENGTH PAIN RELIEVING GEL  NDC: 49614-412-26  Provides Hours of Long Lasting Relief from:  > Arthritis  > Backache  > Sore Muscles  > Stiff Joints  100%  GUARANTEED SATISFACTION  Fast Acting  Greaseless  Vanishing Scent  4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL

0  91899 41226  5  LOT  Drug Facts  Distributed By: Medicine Shoppe International, Inc.  St. Louis, MO 63132  A Cardinal Health Company  CIN 1679646  100%  GUARANTEED SATISFACTION

The Medicine Shoppe Extra Strength Pain Relieving Gel 4oz/118ml (

49614-412-26)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THE MEDICINE SHOPPE EXTRA STRENGTH PAIN RELIEVING 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49614-412
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49614-412-26	1 in 1 CARTON	01/26/2012
1		118 mL in 1 TUBE; 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	01/26/2012

Labeler - Medicine Shoppe International Inc (071997654)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		117101131	manufacture(49614-412)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		557434805	manufacture(49614-412)