FDA.reportPublic FDA data

Hua Tuo

Manufacturer
GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY
Effective date
2019-10-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:01:21

Label at a glance#

ProductHua Tuo Medicated Plaster Extra Strength
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure11 sections

Indications and uses

For the temporary relief of minor pains and aches of muscles and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Dosage and administration

■ Adults and children 12 years of age and older remove the clear film backing and apply to affected area not more than 3 to 4 times daily ■ Children under 12 years of age, consult a doctor before using. ■ Use caution when applying to hairy skin areas, highly adhesive plaster can hurt when removing.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 3%
Camphor10%

Purpose

OTC - PURPOSE SECTION

External Analgesic

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor pains and aches of muscles and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings

WARNINGS SECTION

For external use only ■ Do not use ■ do not apply to wounds or damaged skin

■ discontinue use if excessive irritation of the skin develops ■ condition affect children uner 12 years of age

When using this product

OTC - WHEN USING SECTION

■ Avoid contact with the eyes or mucus membranes ■ do not bandage tightly ■ Do not use otherwise than as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

■ redness is present

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 12 years of age and older remove the clear film backing

and apply to affected area not more than 3 to 4 times daily

■ Children under 12 years of age, consult a doctor before using.

■ Use caution when applying to hairy skin areas, highly adhesive plaster can hurt when removing.

Other Information

SPL UNCLASSIFIED SECTION

■ Store at 68-77ºF (20-25C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

angelica dahurica root, angelica pubescens root, boswellia sacra whole, carthamus tinctorius flower, cinnamon oil, clove oil, commiphora africana resin, drynaria fortunei root, eleutherococcus nodiflorus root bark, ginger, glechoma longituba whole, panax notoginseng root, saposhnikovia divaricata root, schizonepeta tenuifolia flowering top

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1537783camphor 10 % / menthol 3 % Medicated PatchPSN4
1537783camphor 0.1 MG/MG / menthol 0.03 MG/MG Medicated PatchSCD4
1537783camphor 10 % / menthol 3 % Medicated PatchSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61821-100-052021-01-29C16284748780-1ba0f9c33-485a-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61821-100-05Hua TuoMedicated Plaster Extra Strength5 in 1 BOXPATCH54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61821-100HUA TUO MEDICATED PLASTER EXTRA STRENGTH (MENTHOL CAMPHOR) PATCH [GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY]4Legacy NDC, 1 package rows20191101_4a5b3266-be6b-4af8-be24-bc3edb7cd304.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET1
MENTHOLACTIVE MOIETYL7T10EIP3A1
ANGELICA DAHURICA ROOTINACTIVE INGREDIENT1V63N2S9721
ANGELICA PUBESCENS ROOTINACTIVE INGREDIENT0MF1EI01KJ1
BOSWELLIA SACRA WHOLEINACTIVE INGREDIENT8O600AZL0W1
CARTHAMUS TINCTORIUS FLOWER BUDINACTIVE INGREDIENTB86IS274O01
CINNAMON OILINACTIVE INGREDIENTE5GY4I6YCZ1
CLOVE OILINACTIVE INGREDIENT578389D6D01
COMMIPHORA AFRICANA RESININACTIVE INGREDIENTW30OSW7A0S1
DRYNARIA FORTUNEI ROOTINACTIVE INGREDIENT731W842X8Q1
ELEUTHEROCOCCUS NODIFLORUS ROOT BARKINACTIVE INGREDIENTW7PRK433YB1
GINGERINACTIVE INGREDIENTC5529G5JPQ1
GLECHOMA LONGITUBA WHOLEINACTIVE INGREDIENT79GOE5902E1
PANAX NOTOGINSENG ROOTINACTIVE INGREDIENTGQX1C1175U1
SAPOSHNIKOVIA DIVARICATA ROOTINACTIVE INGREDIENT8H84LFK2QD1
SCHIZONEPETA TENUIFOLIA FLOWERING TOPINACTIVE INGREDIENT2FN3BA1MZE1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61821-10061821-100-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANGELICA DAHURICA ROOT1V63N2S972IACT
ANGELICA PUBESCENS ROOT0MF1EI01KJIACT
BOSWELLIA SACRA WHOLE8O600AZL0WIACT
CARTHAMUS TINCTORIUS FLOWER BUDB86IS274O0IACT
CINNAMON OILE5GY4I6YCZIACT
CLOVE OIL578389D6D0IACT
COMMIPHORA AFRICANA RESINW30OSW7A0SIACT
DRYNARIA FORTUNEI ROOT731W842X8QIACT
ELEUTHEROCOCCUS NODIFLORUS ROOT BARKW7PRK433YBIACT
GINGERC5529G5JPQIACT
GLECHOMA LONGITUBA WHOLE79GOE5902EIACT
PANAX NOTOGINSENG ROOTGQX1C1175UIACT
SAPOSHNIKOVIA DIVARICATA ROOT8H84LFK2QDIACT
NEPETA TENUIFOLIA FLOWERING TOP2FN3BA1MZEIACT
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 11 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CLOVE OILCLOVE OIL578389D6D0PASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
GINGERGINGERC5529G5JPQELIXIR / ORAL10 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
GINGERGINGERC5529G5JPQSYRUP / ORAL0.05 ml/5mlExact identifier — unii candidate
2 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZPASTILLE / ORAL4 mgExact identifier — unii candidate
6 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
3 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZSUSPENSION / ORAL0.2 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
6 equally ranked IID candidates
CLOVE OILCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
3 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZELIXIR / ORAL0.58 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
6 equally ranked IID candidates

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
963bd6d1-4337-07b4-e053-2a95a90aba354a5b3266-be6b-4af8-be24-bc3edb7cd3042019-10-31WarningsExact identifier
spl id: 963bd6d1-4337-07b4-e053-2a95a90aba35
spl set id: 4a5b3266-be6b-4af8-be24-bc3edb7cd304

Reported adverse events (FAERS/openFDA)#

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