COLD AND HOT PAIN RELIEF - menthol patch
Kareway Product, Inc.

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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Drug Facts

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with:

arthritis
muscle strains
simple backache
bursitis
cramps
tendonitis
muscle sprains
bruises

Warnings

For external use only

When using this product

use only as directed
do not bandage tightly
do not use a heating pad
avoid contact with eyes and mucous membrane
do not apply to wounds or damaged skin
do not use if you are allergic to any ingredients of this product

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
redness is present
irritation develops

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

Remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
Carefully remove backing from patch
Apply one patch to affected area
Repeat as necessary, but no more than 4 times daily

Children under 12 years of age: Ask a doctor

Other information

store at room temperature

Inactive ingredients

aluminium glycinate, 1,3-butylene glycol, carboxymethylcellulose sodium, concentrated glycerin, diethylene glycol monoethyl ether, disodium edetate, methyl parahydroxybenzoate, polyacrylic acid solution, polysorbate 80, propyl parahydroxybenzoate, purified water, tartaric acid, titanium dioxide

package label

Cold and Hot Pain Relief Patch

COLD AND HOT PAIN RELIEF
menthol patch

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:67510-0030
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (MENTHOL)	MENTHOL	400 mg

Ingredient Name	Strength
Inactive Ingredients
DIHYDROXYALUMINUM AMINOACETATE
BUTYLENE GLYCOL
CARBOXYMETHYLCELLULOSE SODIUM
GLYCERIN
DIETHYLENE GLYCOL MONOETHYL ETHER
EDETATE DISODIUM
METHYLPARABEN
POLYSORBATE 80
PROPYLPARABEN
WATER
TARTARIC ACID
TITANIUM DIOXIDE

#	Item Code	Package Description
Packaging
1	NDC:67510-0030-2	1 in 1 CARTON
1		2 in 1 POUCH
2	NDC:67510-0030-3	1 in 1 CARTON
2		3 in 1 POUCH
3	NDC:67510-0030-5	1 in 1 CARTON
3		5 in 1 POUCH
4	NDC:67510-0030-6	1 in 1 CARTON
4		6 in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/12/2011

Labeler - Kareway Product, Inc. (121840057)

Revised: 9/2011

Document Id: e9b295be-37f8-431b-b7bd-2d93e4dba6ec

Set id: 46345292-2a99-4278-8693-7e4a4097d14f

Version: 1

Effective Time: 20110912

Kareway Product, Inc.