HOT/COLD MEDICATED PATCH- hot cold patch patch

Hot/Cold Medicated Patch by

Drug Labeling and Warnings

Hot/Cold Medicated Patch by is a Otc medication manufactured, distributed, or labeled by Dynarex. 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
• sypmtoms clear up and occur again within a few days

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 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

Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Label

INGREDIENTS AND APPEARANCE

HOT/COLD MEDICATED PATCH 
hot cold patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	285 mg  in 5700 mg

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
TARTARIC ACID (UNII: W4888I119H)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-201-10	180 in 1 CASE	12/13/2019
1		5 in 1 BOX
1		285 mg in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 67777-201-20	180 in 1 CASE	12/13/2019
2		5 in 1 BOX
2		285 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	12/13/2019

Labeler - Dynarex (008124539)

Registrant - Dynarex (008124539)