TOKUHON-A EXTERNAL ANALGESIC 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 Analgesic Pain Relieving Medicated Patch

TOKUHON-A External Analgesic Pain Relieving Medicated Patch


Active ingredients

Camphor 3.27%
Menthol 4.56%
Methyl Salicylate 10.12%

Purpose

External Analgesic

Uses

For the temporary 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

  • on wounds
  • on damaged skin
  • otherwise than as directed

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

Do not use on wet or sweaty skin.  Clean and dry the affected area before application.  Remove attached film from medicated patch and apply adhesive side to the affected area.  Adults and children 2 years of age and older:  Apply to affected area not more than 3 times a day because it will remain effective for about 8 hours in normal conditions.  It will be more effected when used after shower or massage.  Children under 2 years of age:  Do not use.  Consult a doctor.

Other Information

  • Do not apply on extremely hairy surface of skin.  Highly adhesive patch may hurt skin upon removal of product.
  • Preserve in tight container upon removal of product.
  • Storage temperature not more than 86 o F (30 o C).

Inactive Ingredients

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

MANUFACTURER:

TOKUHON CORPORATION
2-28-8 Shiba, Minato-ku,
Tokyo 105-0014, Japan

U.S. DISTRIBUTOR:

SOLSTICE MEDICINE COMPANY
215 West Ann Street,
Los Angeles, CA 90012
Toll Free: 1-888-221-3496
www.solsticemed.com

Made in Japan

SEALED FOR SAFETY

External Analgesic Pain Relieving Medicated Patch  TOKUHON-A  20 Patches   Each Patch 2.5 in x 1.6 in. (6.5cm x 4.2 cm)

TOKUHON-A External Analgesic Pain Relieving Medicated Patch 20 Patches (48407-0007-6) | TOKUHON-A External Analgesic Pain Relieving Medicated Patch 40 Patches (48407-0007-7)

TOKUHON 20

TOKUHON-A EXTERNAL ANALGESIC PAIN RELIEVING MEDICATED 
camphor (natural), menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48407-0007
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:48407-0007-620 in 1 CARTON09/09/201601/01/2017
1455 mg in 1 PATCH; Type 0: Not a Combination Product
2NDC:48407-0007-740 in 1 CARTON09/09/201601/01/2017
2455 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 finalpart34804/04/201301/01/2017
Labeler - Tokuhon Corporation (715715442)
Registrant - Tokuhon Corporation (715715442)
Establishment
NameAddressID/FEIBusiness Operations
Tokuhon Corporation715715442manufacture(48407-0007)

Revised: 12/2017
Document Id: 60c5e3c7-e439-46f7-e053-2991aa0a9ff1
Set id: 33316a1e-83fc-432c-a7ec-2dbf60172464
Version: 3
Effective Time: 20171220
 
Tokuhon Corporation