COLD AND HOT PAIN RELIEF- menthol patch

Cold and Hot Pain Relief by

Drug Labeling and Warnings

Cold and Hot Pain Relief by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

COLD AND HOT PAIN RELIEF 
menthol patch

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	400 mg

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0030-2	1 in 1 CARTON	09/12/2011
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67510-0030-4	1 in 1 CARTON	09/12/2011
2		4 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 67510-0030-3	1 in 1 CARTON	09/12/2011
3		3 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 67510-0030-5	1 in 1 CARTON	09/12/2016
4		5 in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 67510-0030-6	1 in 1 CARTON	09/12/2016
5		6 in 1 POUCH; 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	09/12/2011

Labeler - Kareway Product, Inc. (121840057)