EXTRA STRENGTH HUA TUO PAIN RELIEF- camphor and menthol patch 
MADISON ONE ACME INC

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 Facts

Active Ingredients
Camphor 3.1%
Menthol 2.6%

Purpose
External Analgesic
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

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

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

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

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 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

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

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

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

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

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

Box-01.jpg

EXTRA STRENGTH HUA TUO PAIN RELIEF 
camphor and menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-630
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55614-630-011 in 1 BOX04/01/2020
16 in 1 POUCH
11 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 finalpart34804/01/2020
Labeler - MADISON ONE ACME INC (096196758)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-630)

Revised: 4/2020
Document Id: 6accfc36-fadd-4978-9927-55e5836a238b
Set id: 0f269a41-4b56-4e22-b9cb-17d99bf76a57
Version: 1
Effective Time: 20200413
 
MADISON ONE ACME INC