COLD AND HOT MEDICATED- menthol patch

COLD AND HOT MEDICATED by

Drug Labeling and Warnings

COLD AND HOT MEDICATED by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Uses

Temporarily relieve minor pain associated with:
arthritis simple backache muscle strains bursitis tendonitis strains bruises cramps

WARNINGS

External Use Only.

When using this product use only as directed do not bandage tightly or use with a heating pad
avoid contact with eyes and mucous membranes do not apply to wounds or damaged skin.

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 skin 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 12 years of age and older:

• Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch
• Should be used up to 8 hours
• Should be used no more than 3 to 4 times daily
• Children under 12 years of age: Consult a doctor.

Other Information

• store at room temperature 68° to 77°F (20° to 25°C)

Inactive Ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80

SPL UNCLASSIFIED SECTION

*Compare to the active ingredient in Icy Hot® Patch

EXTRA STRENGTH

Contains Menthol 5%

Pain relieving ointment on a breathable adhesive pad

EXTRA STRENGTH COLD & HOT MEDICATED PATCH works on contact providing pain relief that lasts for hours. The thin, flexible patch is comfortable to wear and is easy to remove.

FAST RELIEF OF MINOR ACHES AND PAINS

*This product is NOT manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot® Patch.

Distributed by:

Universal Distribution Center

96 Distribution Boulevard Edison, NJ 08817

Made in P.R.C.

Packaging

INGREDIENTS AND APPEARANCE

COLD AND HOT MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-422
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
KAOLIN (UNII: 24H4NWX5CO)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
TARTARIC ACID (UNII: W4888I119H)
POVIDONE K90 (UNII: RDH86HJV5Z)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALCOHOL 95% (UNII: 7528N5H79B)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-422-41	2 in 1 POUCH	11/25/2024
1		8.5 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 52000-422-42	24 in 1 BOX	11/25/2024
2		2 in 1 POUCH
2		8.5 g 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 Drug	M017	11/25/2024

Labeler - Universal Distribution Center LLC (019180459)