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TOKUHON-A External Analgesic Pain Relieving Medicated

Dosage form: patch
Ingredients: CAMPHOR (SYNTHETIC) 3.27mg in 100mg, MENTHOL 4.56mg in 100mg, METHYL SALICYLATE 10.12mg in 100mg
Labeler: Tokuhon Corporation
NDC code: 48407-0007

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-A EXTERNAL ANALGESIC PAIN RELIEVING MEDICATED
camphor (natural), menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48407-0007
Route of Administration	TRANSDERMAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC))	CAMPHOR (SYNTHETIC)	3.27 mg in 100 mg
MENTHOL (MENTHOL)	MENTHOL	4.56 mg in 100 mg
METHYL SALICYLATE (SALICYLIC ACID)	METHYL SALICYLATE	10.12 mg in 100 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE
NATURAL LATEX RUBBER
ZINC OXIDE

Packaging
#	Item Code	Package Description
1	NDC:48407-0007-6	20 PATCH in 1 CARTON
1		455 mg in 1 PATCH
2	NDC:48407-0007-7	40 PATCH in 1 CARTON
2		455 mg in 1 PATCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/04/2013

Labeler - Tokuhon Corporation (715715442)

Registrant - Tokuhon Corporation (715715442)

Establishment
Name	Address	ID/FEI	Operations
Tokuhon Corporation		715715442	manufacture(48407-0007)

Revised: 09/2016

Document Id: 3bddc9da-61f5-4998-e054-00144ff88e88

Set id: 33316a1e-83fc-432c-a7ec-2dbf60172464

Version: 2

Effective Time: 20160906

Tokuhon Corporation

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Migraine 101