FDA.reportPublic FDA data

Takahi Hot Medicated Plaster

Manufacturer
Indo Abadi Sari Makmur, PT
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
32801
Source
full-release
Hydrated at
2026-05-31 23:47:04

Label at a glance#

ProductTakahi Hot Medicated Plaster
Active ingredientCAMPHOR (SYNTHETIC), CAPSICUM OLEORESIN
Label structure11 sections

Indications and uses

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

Dosage and administration

- Wash the skin with soap and water; and dry it well. - Remove the covering material from the adhesive side of the plaster. - Place the plaster on the aching spot and press it to the skin until it sticks. - After use, remove the plaster by taking it at one corner and tear it off. If there are any places of plaster remaining, they can be removed easily by rubbing the spot with alcohol or spirit. The plaster should ...

Storage and handling

Store at temperature not exceeding 30°C (86°F).

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor (Synthetic)    2.59%

Capsicum Oleoresin  3.29%

Purpose

OTC - PURPOSE SECTION

Camphor (Synthetic)   Topical Analgesic
Capsicum Oleoresin     Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

- Wash the skin with soap and water; and dry it well.
- Remove the covering material from the adhesive side of the plaster.
- Place the plaster on the aching spot and press it to the skin until it sticks.
- After use, remove the plaster by taking it at one corner and tear it off. If there are any places of plaster remaining, they can be removed easily by rubbing the spot with alcohol or spirit. The plaster should be worn for 2 or 3 days. In extreme case, a second one may be applied.

Warnings

WARNINGS SECTION

External Use Only. Do not use for children below 12 years of age.

Warnings

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.

Stop Use and Ask a Doctor If

OTC - STOP USE SECTION

- the situation gets worst.
- symptoms persist after 7 days use.
- if undesirable effects are encountered.
- if you are pregnant.
- you are allergic to lactation.

Other Information

STORAGE AND HANDLING SECTION

Store at temperature not exceeding 30°C (86°F).

Manufactured by

SPL UNCLASSIFIED SECTION

INDO ABADI SARIMAKMUR, PT.
Dusun Ngablak, Ds. Gempolkurung, No. 168M
Kec. Menganti, Kab. Gresik - Jawa Timur
Indonesia

Inactive Ingredients

INACTIVE INGREDIENT SECTION

BORNEOL, NATURAL LATEX RUBBER, ROSIN, SILICON DIOXIDE, GLYCEROL ESTER OF HYDROGENATED ROSIN, LANOLIN, GINGER OIL, HEXANE

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug FactsDrug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1999400camphor 2.59 % / capsicum extract 3.29 % Medicated PatchPSN32801
1999400camphor 0.0259 MG/MG / Capsicum extract 0.0329 MG/MG Medicated PatchSCD32801
1999400camphor 2.59 % / capsicum extract 3.29 % Medicated PatchSY32801

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70815-003-102023-07-28C16284748780-10191ceaa-64e1-198a-e063-dbdaa90aec3eIndo Abadi Sari Makmur, PT
70815-003-252023-07-28C16284748780-10191ceaa-64e1-198a-e063-dbdaa90aec3eIndo Abadi Sari Makmur, PT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70815-003-10Takahi Hot Medicated Plaster1 in 1 BOXPLASTER132801
70815-003-10Takahi Hot Medicated Plaster0.3 g in 1 PATCHPLASTER0.332801
70815-003-25Takahi Hot Medicated Plaster1 in 1 BOXPLASTER132801
70815-003-25Takahi Hot Medicated Plaster0.6 g in 1 PATCHPLASTER0.632801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70815-003TAKAHI HOT MEDICATED PLASTER (CAMPHOR) PLASTER [INDO ABADI SARI MAKMUR, PT]32801Legacy NDC, 4 package rows20220115_f6c80d9b-b73f-4866-8a29-576524c69e34.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70815-00370815-003-10, 70815-003-25

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
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
CAPSICUM OLEORESINUW86K581WYACTIR
BORNEOLM89NIB437XIACT
NATURAL LATEX RUBBER2LQ0UUW8INIACT
ROSIN88S87KL877IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCEROL ESTER OF HYDROGENATED ROSINXH62RP786NIACT
LANOLIN7EV65EAW6HIACT
GINGER OILSAS9Z1SVUKIACT
HEXANE2DDG612ED8IACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9bdf1814-f8df-46c0-b569-75419a4c26a0f6c80d9b-b73f-4866-8a29-576524c69e342022-01-14WarningsExact identifier
spl id: 9bdf1814-f8df-46c0-b569-75419a4c26a0
spl set id: f6c80d9b-b73f-4866-8a29-576524c69e34

Reported adverse events (FAERS/openFDA)#

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