Medicated Pain Relief

Manufacturer: Kareway Product, Inc. | TDS Pharm Co., Ltd.
Effective date: 2019-03-07
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:58:43

Label at a glance#

ProductMedicated Pain Relief

Active ingredientMENTHOL

Label structure8 sections

Indications and uses

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

Dosage and administration

Adults and children over 12 years: Carefully remove backing film from patch Apply one patch to affected area Repeat as necessary, but no more than 4 times daily. Children 12 years or younger: ask a doctor

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

L-Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with:

arthritis
simple backache
bursitis
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 or use a heating pad
avoid contact with eyes and mucous membrane
do not apply to wounds or damaged skin

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 over 12 years:

Carefully remove backing film from patch
Apply one patch to affected area
Repeat as necessary, but no more than 4 times daily.

Children 12 years or younger:

ask a doctor

Other Information

STORAGE AND HANDLING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Relief Medicated Patch

carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
420222	menthol 5 % Medicated Patch	PSN	2
420222	menthol 0.05 MG/MG Medicated Patch	SCD	2
420222	menthol 5 % Medicated Patch	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
67510-1301-5	2022-01-28	C162847	48780-1	d6a99b39-845f-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67510-1301-5	Medicated Pain Relief	1 in 1 CARTON	PATCH	1		2
67510-1301-5	Medicated Pain Relief	5 in 1 POUCH	PATCH	5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67510-1301	MEDICATED PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]	2	Legacy NDC, 2 package rows	20190308_73fdd47b-6c3a-9886-e053-2991aa0a1ee8.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Medicated Pain Relief
Menthol
WATER
SODIUM POLYACRYLATE (8000 MW)
DIHYDROXYALUMINUM AMINOACETATE
KAOLIN
GLYCERIN
POVIDONE
METHYLPARABEN
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
PROPYLPARABEN
POLYACRYLIC ACID (8000 MW)
TARTARIC ACID
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67510-1301	67510-1301-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM POLYACRYLATE (8000 MW)	285CYO341L	IACT
DIHYDROXYALUMINUM AMINOACETATE	DO250MG0W6	IACT
KAOLIN	24H4NWX5CO	IACT
GLYCERIN	PDC6A3C0OX	IACT
POVIDONE	FZ989GH94E	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
POLYACRYLIC ACID (8000 MW)	73861X4K5F	IACT
TARTARIC ACID	W4888I119H	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
MENTHOL	L7T10EIP3A	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
838a5a74-d45f-d6d1-e053-2a91aa0aa512			73fdd47b-6c3a-9886-e053-2991aa0a1ee8	2019-03-07	Warnings	Exact identifier spl id: 838a5a74-d45f-d6d1-e053-2a91aa0aa512 spl set id: 73fdd47b-6c3a-9886-e053-2991aa0a1ee8

Reported adverse events (FAERS/openFDA)#

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