TOKUHON-A EXTERNAL PAIN RELIEVING MEDICATED- camphor (natural), menthol, methyl salicylate patch 
Tokuhon Corporation

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.

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TOKUHON-A External Pain Relieving Medicated Patch

Active ingredients

Camphor 3.27%
Menthol 4.56%
Methyl Salicylate 10.12%

Purpose

Pain relief

Uses

Temporarily relief of minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do not use

  • otherwise than directed
  • on wounds
  • on damaged skin
  • If you are allergic to aspirin or salicylate.
  • If you are allergic to any ingredients of this product.

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if:

  • excessive irritation of the skin develops
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean and dry the affected area before application.  Do not use on wet or sweaty skin. 
  • Remove the attached film from patch and apply adhesive side to affected area. 
  • Adults and children 7 years of age and older:  Apply to affected area not more than 3 times daily. It will remain effective for about 8 hours under normal conditions. 
  • Children under 7 years of age:  Do not use.  Consult a doctor.

Other Information

  • Do not apply on extremely hairy surfaces of skin.  Highly adhesive patch may hurt skin upon removal of product.
  • After opening, keep in original box and store in tight container.
  • Store at temperatures not more than 86 oF(25 oC)

Inactive Ingredients

Butylated Hydroxytoluene, Denaturalized Rosin Ester, Natural Rubber, Polyisobutylene, Polyisoprene, Styrene-butadiene Rubber, Zinc Oxide

MANUFACTURER:

MANUFACTURER:
TOKUHON CORPORATION
Tokyo, Japan

HAWAII DISTRIBUTOR:
KOTAKE SHOKAI, LTD.,
1812 Kalani St., Honolulu,
Hawaii, 96819 U.S.A.
(808)847-3926

MADE IN JAPAN

SEALED FOR SAFETY

External Pain Relieving Medicated Patch  TOKUHON-A  80 Patches   Each Patch 2.5 in x 1.6 in. (6.5cm x 4.2 cm)

Representative Label

Main Panel

Drug Facts

TOKUHON-A EXTERNAL PAIN RELIEVING MEDICATED 
camphor (natural), menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48407-0070
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.27 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.56 mg  in 100 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10.12 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48407-0070-620 in 1 CARTON09/09/201601/01/2017
1455 mg in 1 PATCH; Type 0: Not a Combination Product
2NDC:48407-0070-740 in 1 CARTON09/09/201601/01/2017
2455 mg in 1 PATCH; Type 0: Not a Combination Product
3NDC:48407-0070-880 in 1 CARTON09/09/201601/01/2017
3455 mg in 1 PATCH; Type 0: Not a Combination Product
4NDC:48407-0070-924 in 1 CARTON09/09/201601/01/2017
4455 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/26/201301/01/2017
Labeler - Tokuhon Corporation (715715442)
Registrant - Tokuhon Corporation (715715442)
Establishment
NameAddressID/FEIBusiness Operations
Tokuhon Corporation715715442manufacture(48407-0070)

Revised: 12/2017
Document Id: 60c5e3c7-e44c-46f7-e053-2991aa0a9ff1
Set id: d4ceb7b5-c7a6-4ee6-b82c-e4f60020b33a
Version: 3
Effective Time: 20171220
 
Tokuhon Corporation