COLD/HOT MEDICATED PATCHES- medicated patches patch

Cold/Hot Medicated Patches by

Drug Labeling and Warnings

Cold/Hot Medicated Patches by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 5%

Purpose

Topical analgesic

Use

Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, strains, sprains, bruises

Warnings

For external use only

Do not use

on wounds or damaged skin, with a heating pad, if you are allergic to any ingredients of this product

When using this product

use only as directed, avoid contact with the eyes, mucous membranes or rashes

Stop use and ask a doctor if

• excessive redness or irritation is present
• conditions worsen
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

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

Directions

Adults and children 12 years of age and over

• clean and dry affected area
• remove film from patch and apply to the skin
• apply 1 patch at a time to affected area, not more than 3 to 4 times daily
• wear each patch up to 8 hours maximum

Children under 12 years of age

• consult a doctor

Other information

• Avoid storing product in direct sunlight
• Protect product from excessive moisture

Inactive ingredients

Aluminum Hydroxide, Castor Oil, Disodium EDTA, Glycerin, Isopropyl Myristate, Kaolin, Polysorbate, Polyvinyl Alcohol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Label NDC:

67777-145-10

Label NDC:

67777-145-20

Label NDC:

67777-145-30

INGREDIENTS AND APPEARANCE

COLD/HOT MEDICATED PATCHES 
medicated patches patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 5 mg

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
CASTOR OIL (UNII: D5340Y2I9G)
KAOLIN (UNII: 24H4NWX5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-145-10	180 in 1 CASE	08/15/2018
1		5 in 1 BOX
1		5 mg in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 67777-145-20	180 in 1 CASE	08/15/2018
2		5 in 1 BOX
2		5 mg in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 67777-145-30	108 in 1 CASE	08/15/2018
3		3 in 1 BOX
3		5 mg in 1 PATCH; 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	08/15/2018

Labeler - Dynarex Corporation (008124539)