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NDC 70815-0003-10 Takahi Hot Medicated Plaster 2.59; 3.29 g/100g; g/100g Details

Takahi Hot Medicated Plaster 2.59; 3.29 g/100g; g/100g

Takahi Hot Medicated Plaster is a TRANSDERMAL PLASTER in the HUMAN OTC DRUG category. It is labeled and distributed by Indo Abadi Sari Makmur, PT. The primary component is CAMPHOR (SYNTHETIC); CAPSICUM OLEORESIN.

Product Information

NDC	70815-0003
Product ID	70815-003_9bdf1814-f8df-46c0-b569-75419a4c26a0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Takahi Hot Medicated Plaster
Proprietary Name Suffix	n/a
Non-Proprietary Name	Camphor
Product Type	HUMAN OTC DRUG
Dosage Form	PLASTER
Route	TRANSDERMAL
Active Ingredient Strength	2.59; 3.29
Active Ingredient Units	g/100g; g/100g
Substance Name	CAMPHOR (SYNTHETIC); CAPSICUM OLEORESIN
Labeler Name	Indo Abadi Sari Makmur, PT
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70815-0003-10 (70815000310)

Pricing Information	N/A
NDC Package Code	70815-003-10
Billing NDC	70815000310
Package	1 PATCH in 1 BOX (70815-003-10) / .3 g in 1 PATCH
Marketing Start Date	2016-07-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f6c80d9b-b73f-4866-8a29-576524c69e34 Details

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

INGREDIENTS AND APPEARANCE

TAKAHI HOT MEDICATED PLASTER

camphor plaster

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70815-003
Route of Administration	TRANSDERMAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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 OLEORESIN	3.29 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70815-003-10	1 in 1 BOX	07/31/2016
1		0.3 g in 1 PATCH; Type 1: Convenience Kit of Co-Package
2	NDC:70815-003-25	1 in 1 BOX	07/31/2016
2		0.6 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/31/2016

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

Search by Drug Name or NDC

NDC 70815-0003-10 Takahi Hot Medicated Plaster 2.59; 3.29 g/100g; g/100g Details

Takahi Hot Medicated Plaster 2.59; 3.29 g/100g; g/100g

Product Information

Package

Package Images

NDC 70815-0003-10 (70815000310)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f6c80d9b-b73f-4866-8a29-576524c69e34 Details

Active Ingredients

Purpose

Uses

DIRECTIONS

Warnings

Warnings

Stop Use and Ask a Doctor If

Other Information

Manufactured by

Inactive Ingredients

Drug Facts

INGREDIENTS AND APPEARANCE

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