EXTRA STRENGTH HUA TUO PAIN RELIEF- camphor and menthol patch

EXTRA STRENGTH HUA TUO PAIN RELIEF by

Drug Labeling and Warnings

EXTRA STRENGTH HUA TUO PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by MADISON ONE ACME INC, Zhejiang Dingtai Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Camphor 3.1%
Menthol 2.6%

PURPOSE

Purpose
External Analgesic
External Analgesic

INDICATIONS & USAGE

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

WARNINGS

Warnings
For external use only

Allergy alert: This product contains natural rubber latex which may cause allergic reactions.

DO NOT USE

Do not use■ on irritated or damaged skin
■ on wounds
■ if you are allergic to any ingredient in this product

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you have
■ any concerns about using this product

WHEN USING

When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch

STOP USE

Stop use and ask a doctor if
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ excessive irritation of the skin develops
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
■ when using for pain of arthritis:
   ■ pain persists for more than 10 days
   ■ redness is present
   ■ in conditions affecting children under 12 years of age

ADVERSE REACTIONS

Report any unexpected side effects from the use of this product to the FDA MedWatch Program.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
■ adults and children 2 years of age and older: remove the protective film from the patch. Apply to affected area not more than 3 to 4 times daily.
■ children under 2 years of age: consult your physician

STORAGE AND HANDLING

Other information
■ keep patches tightly closed in the zip-lock pouch
■ store at 15º to 30º C (59º to 86º F) in a dry place away from sunlight

INACTIVE INGREDIENT

Inactive ingredients
Ocimum gratissimum leaf oil, butylated hydroxytoluene, cinnamon oil, saposhnikovia divaricata root, angelica dahurica root, ginger, lanolin, natural latex rubber, petrolatum, rosin, safflower, nepeta tenuifolia flowering top, and zinc oxide on an elastic cloth and covered with a protective paper film.

QUESTIONS

Questions or comments?
(888) 221-3496 M-F 9 am to 5 pm
■ you may also report serious side effects to this phone number

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH HUA TUO PAIN RELIEF PATCH

NDC: 55614-630-01

An effective herbal patch for the relief of aches and pains from muscles, strains, arthritis, backache, joints, bruises, sprains.

6 Patches
Each Patch 7 x 10 cm (2.75 x 4 in)

Apply for 12 Hours

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH HUA TUO PAIN RELIEF 
camphor and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55614-630
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCIMUM GRATISSIMUM LEAF OIL (UNII: AVG2506KDV)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CINNAMON OIL (UNII: E5GY4I6YCZ)
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
GINGER (UNII: C5529G5JPQ)
LANOLIN (UNII: 7EV65EAW6H)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
PETROLATUM (UNII: 4T6H12BN9U)
ROSIN (UNII: 88S87KL877)
SAFFLOWER (UNII: 4VBL71TY4Y)
NEPETA TENUIFOLIA FLOWERING TOP (UNII: 2FN3BA1MZE)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55614-630-01	1 in 1 BOX	04/01/2020
1		6 in 1 POUCH
1		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2020

Labeler - MADISON ONE ACME INC (096196758)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd		420598724	manufacture(55614-630)