EXTRA STRENGTH HUA TUO PAIN RELIEF

Manufacturer
MADISON ONE ACME INC | Zhejiang Dingtai Pharmaceutical Co., Ltd
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:43:03

Label at a glance#

ProductEXTRA STRENGTH HUA TUO PAIN RELIEF
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure15 sections

Storage and handling

Other information ■ keep patches tightly closed in the zip-lock pouch ■ store at 15º to 30º C (59º to 86º F) in a dry place away from sunlight

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Camphor 3.1%
Menthol 2.6%

OTC - PURPOSE SECTION

Purpose
External Analgesic
External Analgesic

INDICATIONS & USAGE SECTION

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

WARNINGS SECTION

Warnings
For external use only

Allergy alert:
This product contains natural rubber latex which may cause allergic reactions.

OTC - DO NOT USE SECTION

Do not use■ on irritated or damaged skin
■ on wounds
■ if you are allergic to any ingredient in this product

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you have
■ any concerns about using this product

OTC - WHEN USING SECTION

When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch

OTC - STOP USE SECTION

Stop use and ask a doctor if
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ excessive irritation of the skin develops
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
■ when using for pain of arthritis:
   ■ pain persists for more than 10 days
   ■ redness is present
   ■ in conditions affecting children under 12 years of age

ADVERSE REACTIONS SECTION

Report any unexpected side effectsfrom the use of this product to the FDA MedWatch Program.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
■ adults and children 2 years of age and older: remove the protective film from the patch. Apply to affected area not more than 3 to 4 times daily.
■ children under 2 years of age: consult your physician

STORAGE AND HANDLING SECTION

Other information
■ keep patches tightly closed in the zip-lock pouch
■ store at 15º to 30º C (59º to 86º F) in a dry place away from sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients
Ocimum gratissimum leaf oil, butylated hydroxytoluene, cinnamon oil, saposhnikovia divaricata root, angelica dahurica root, ginger, lanolin, natural latex rubber, petrolatum, rosin, safflower, nepeta tenuifolia flowering top, and zinc oxide on an elastic cloth and covered with a protective paper film.

OTC - QUESTIONS SECTION

Questions or comments?
(888) 221-3496 M-F 9 am to 5 pm
■ you may also report serious side effects to this phone number

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH HUA TUO PAIN RELIEF PATCH

NDC 55614-630-01

An effective herbal patch for the relief of aches and pains from muscles, strains, arthritis, backache, joints, bruises, sprains.

6 Patches
Each Patch 7 x 10 cm (2.75 x 4 in)

Apply for 12 Hours

Box-01.jpgBox-01.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2118540camphor 3.1 % / menthol 2.6 % Medicated PatchPSN3
2118540camphor 0.031 MG/MG / menthol 0.026 MG/MG Medicated PatchSCD3
2118540camphor 3.1 % / menthol 2.6 % Medicated PatchSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55614-630-01EXTRA STRENGTH HUA TUO PAIN RELIEF6 in 1 POUCHPATCH63
55614-630-01EXTRA STRENGTH HUA TUO PAIN RELIEF1 in 1 BOXPATCH13

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55614-63055614-630-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-11-25full-release2026-06-01 00:39:02

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH HUA TUO PAIN RELIEFCAMPHOR AND MENTHOLMADISON ONE ACME INC0f269a41-4b56-4e22-b9cb-17d99bf76a572025-11-10Warnings, Adverse reactionsExact identifier
ndc (package): 55614-630-01
ndc (product): 55614-630
ndc11 (package): 55614063001
spl id: 4346c26f-c1e0-1ac9-e063-6394a90a6a70
spl set id: 0f269a41-4b56-4e22-b9cb-17d99bf76a57

Reported adverse events (FAERS/openFDA)#

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