Active Ingredients
Camphor (Synthetic) 2.59%
Capsicum Oleoresin 3.29%
Takahi Hot Medicated Plaster
FDA Label NDC 70815-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Indo Abadi Sari Makmur, Pt for the product Takahi Hot Medicated Plaster (NDC 70815-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, directions, warnings, stop use and ask a doctor if, other information, manufactured by, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Camphor (Synthetic) Topical Analgesic
Capsicum Oleoresin Topical Analgesic
Uses
For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.
Directions
- 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
External Use Only. Do not use for children below 12 years of age.
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
- 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
Store at temperature not exceeding 30°C (86°F).
Manufactured By
INDO ABADI SARIMAKMUR, PT.
Dusun Ngablak, Ds. Gempolkurung, No. 168M
Kec. Menganti, Kab. Gresik - Jawa Timur
Indonesia
Inactive Ingredients
BORNEOL, NATURAL LATEX RUBBER, ROSIN, SILICON DIOXIDE, GLYCEROL ESTER OF HYDROGENATED ROSIN, LANOLIN, GINGER OIL, HEXANE
Drug Facts
Image (Carton)
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