HOT COLD MEDICATED PATCHES patch

Hot Cold Medicated Patches by

Drug Labeling and Warnings

Hot Cold Medicated Patches by is a Otc medication manufactured, distributed, or labeled by Henan Enokon Medical Instrument Co., Ltd., Henan Enokon Medical Instrument Co Ltd.. 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 associated with:■simple backache■arthritis■ strains■bruises ■sprains

Warnings

For external use only

Do not use

■ on wounds or damaged skin with a heating pad
■ if you have ever had an allergic reaction to this product or any of its ingredients

When Using

When using this product
■ use only as directed
■ avoid contact with the eyes mucous membranes or rashes ■ do not bandage tightly

Stop Use

Stop use and ask a doctor if
■ localized skin reactions occur, such as rash, itching, redness, irritation pain swelling and blistering
■ conditions worsen
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days

Ask Doctor

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
■ remove patch from the skin after at most 8 hours of application
Children under 12 years of age: consult a doctor

Other information

■ avoid storing product in direct sunlight
■ protect product from excessive moisture
■ store at 20-25°C(68-77°F)

Inactive ingredients

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions

Call 718-975-2586

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOT COLD MEDICATED PATCHES 
hot cold medicated patches patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83559-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
POVIDONE (UNII: FZ989GH94E)
TARTARIC ACID (UNII: W4888I119H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83559-003-01	2 in 1 BAG; Type 0: Not a Combination Product	04/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/07/2024

Labeler - Henan Enokon Medical Instrument Co., Ltd. (701730676)

Establishment
Name	Address	ID/FEI	Business Operations
Henan Enokon Medical Instrument Co Ltd.		701730676	manufacture(83559-003)