Medicated Pain Relief Hot

Manufacturer: Kareway Product, Inc.
Effective date: 2019-07-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:59:49

Label at a glance#

ProductMedicated Pain Relief Hot

Active ingredientMENTHOL, CAPSAICIN

Label structure8 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age and older: Clean and dry affected area. Remove backing film and apply not more than 3 to 4 times daily. Children under 12 years of age: Consult a physician.

Storage and handling

store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

L-Menthol 0.4%

Capsicum Extract (0.002% of Capsaicin)

Purposes

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with:

arthritis
muscle strains
simple backache
bursitis
cramps
tendonitis
muscle sprains
bruises

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

use only as directed
do not bandage tightly
do not use a heating pad
avoid contact with eyes and mucous membrane
do not apply to wounds or damaged skin
do not use if you are allergic to any ingredients of this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
redness is present
irritation develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Clean and dry affected area. Remove backing film and apply not more than 3 to 4 times daily.

Children under 12 years of age: Consult a physician.

Other information

STORAGE AND HANDLING SECTION

store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, Disodium edetate, Tartaric acid, Gelatine, Polyvinyl alcohol, Sodium polyacrylate, Vitamin E acetate, Aloe vera

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67510-0226-2	2021-01-29	C162847	48780-1	ba0f9c33-3c60-a910-e053-dadaa90a0b85	Drug Facts
67510-0226-4	2021-01-29	C162847	48780-1	ba0f9c33-3c60-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67510-0226-2	Medicated Pain Relief Hot	1 in 1 CARTON	PATCH	1	1
67510-0226-2	Medicated Pain Relief Hot	2 in 1 POUCH	PATCH	2	1
67510-0226-4	Medicated Pain Relief Hot	4 in 1 POUCH	PATCH	4	1
67510-0226-4	Medicated Pain Relief Hot	1 in 1 CARTON	PATCH	1	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67510-0226	MEDICATED PAIN RELIEF HOT (MENTHOL, CAPSICUM EXTRACT) PATCH [KAREWAY PRODUCT, INC.]	1	Legacy NDC, 4 package rows	20190703_8cbd5fe1-28db-1db2-e053-2a95a90abadc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Medicated Pain Relief Hot
Menthol, Capsicum extract
WATER
GLYCERIN
EDETATE DISODIUM
TARTARIC ACID
GELATIN
POLYVINYL ALCOHOL
ALPHA-TOCOPHEROL ACETATE
ALOE VERA LEAF
MENTHOL
CAPSAICIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67510-0226	67510-0226-2, 67510-0226-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
TARTARIC ACID	W4888I119H	IACT
GELATIN	2G86QN327L	IACT
POLYVINYL ALCOHOL	532B59J990	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
MENTHOL	L7T10EIP3A	ACTIB
CAPSAICIN	S07O44R1ZM	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8cbd6029-2507-4d8f-e053-2a95a90a5b81			8cbd5fe1-28db-1db2-e053-2a95a90abadc	2019-07-01	Warnings	Exact identifier spl id: 8cbd6029-2507-4d8f-e053-2a95a90a5b81 spl set id: 8cbd5fe1-28db-1db2-e053-2a95a90abadc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.