PAIN RELIEF HOT PATCH patch

PAIN RELIEF HOT Patch by

Drug Labeling and Warnings

PAIN RELIEF HOT Patch by is a Otc medication manufactured, distributed, or labeled by Henan Enokon Medical Instrument Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 3%
Capsaicin 0.083%

Purpose

Topical Analgesic

Use

Temporarily relieves minor pain associated with:

arthritis simple backache bursitis tendonitis muscle strains bruises cramps

Warnings

EXTERNAL USE ONLY

When Using

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

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

Ask Doctor

If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

Adults and Children 12 years of age and older:
Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
Apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: DO NOT use without consulting a doctor.

Other information

For fast relief of minor aches and pains due to:
Arthritis
Strains
Bruises
Sprains

EXTRA STRENGTH PAIN RELIEF HOT PATCH soothes and relieves pain associated with minor aches and pains. It is ideal for small areas such as arm, neck and leg.

FAST-ACTING PAIN RELIEF

Distributed by:
Universal Distribution Center
96 Distribution Boulevard Edison, NJ 08817

MADE IN CHINA

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF HOT PATCH 
pain relief hot patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83559-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 100
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.083 g  in 100

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POVIDONE K90 (UNII: RDH86HJV5Z)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83559-016-01	24 in 1 BOX	01/31/2026
1		2 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 Drug	M017	01/31/2026

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

Establishment
Name	Address	ID/FEI	Business Operations
Henan Enokon Medical Instrument Co., Ltd.		701730676	manufacture(83559-016)