TAKAHI HOT MEDICATED PLASTER- camphor plaster 
Indo Abadi Sari Makmur, PT

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Indo Abadi Sari Makmur, PT

Active Ingredients

Camphor (Synthetic)    2.59%

Capsicum Oleoresin  3.29%

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.

Warnings

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

TAKAHI HOT MEDICATED PLASTER 
camphor plaster
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70815-003
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2.59 g  in 100 g
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSICUM OLEORESIN3.29 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BORNEOL (UNII: M89NIB437X)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
ROSIN (UNII: 88S87KL877)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCEROL ESTER OF HYDROGENATED ROSIN (UNII: XH62RP786N)  
LANOLIN (UNII: 7EV65EAW6H)  
GINGER OIL (UNII: SAS9Z1SVUK)  
HEXANE (UNII: 2DDG612ED8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70815-003-101 in 1 BOX07/31/2016
10.3 g in 1 PATCH; Type 1: Convenience Kit of Co-Package
2NDC:70815-003-251 in 1 BOX07/31/2016
20.6 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/31/2016
Labeler - Indo Abadi Sari Makmur, PT (728715202)

Revised: 1/2022
Document Id: 9bdf1814-f8df-46c0-b569-75419a4c26a0
Set id: f6c80d9b-b73f-4866-8a29-576524c69e34
Version: 32801
Effective Time: 20220114
 
Indo Abadi Sari Makmur, PT