CAPSAICIN HEAT PATCH patch

CAPSAICIN HEAT Patch by

Drug Labeling and Warnings

CAPSAICIN HEAT 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

Capsicum Extract Capsaicin 0.025%

Purpose

Topical Analgesic

Use

For temporary relief of minor aches and pains of muscles & joints associated with:
Simple Backache Arthritis Strains Bruises Sprains

Warnings

EXTERNAL USE ONLY

Do not use

on wounds or damaged skin
with a heating pad
with or at the same times as other external analgesic
if you are allergic to any ingredients of this product

When Using

do not use otherwise than as directed
avoid contact with the eyes, mucous membranes or rashes
do not bandage tightly
discontinue use at least 1 hour before a bath or shower
do not use immediately after a bath or shower

Stop Use

rash, itching or excessive skin irritation develops
conditions worsen
symptoms persist for more than 7 days
symptoms clear up and occur again within few days

Ask Doctor

If pregnant or breast-feeding, ask a health professional before use.
Children under 12 years of age: Consult a doctor.

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 over:
Clean and dry affected area
Remove patch from film
Apply to affected area not more than 3 to 4 times daily
Remove patch from skin after at most 8 hours of application

Other information

Avoid storing product in direct sunlight
Protect product from excessive moisture

Compare to the active ingredient in Salonpas® - Hot Capsicum Patch®

*This product is NOT manufactured or distributed by Hisamitsu®, owner of Salonpas® Hot Capsicum Patch.

Distributed By:

Universal Distribution Center

96 Distribution Boulevard Edison, NJ 08817

MADE IN CHINA

www.universaldc.com

Inactive ingredients

camphor, eucalyptus oil, lanolin, peppermint oil, menthol, methyl salicylate, styrene/isoprene copolymer, zinc oxide

Questions

www.universaldc.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAPSAICIN HEAT PATCH 
capsaicin heat patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83559-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
LANOLIN (UNII: 7EV65EAW6H)
STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW) (UNII: H58HX2GWJ5)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)
ZINC OXIDE (UNII: SOI2LOH54Z)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83559-013-01	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(83559-013)