Label: TAKAHI HOT MEDICATED PLASTER- camphor plaster

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 14, 2022

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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