GUTONG TIEGAO PAIN RELIEVING- camphor and menthol patch 
FOSHAN AQUA GEL BIOTECH CO LTD

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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DRUG FACTS

Active ingredients

Camphor 3.1%

Menthol 1.25%

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 large parts of the body for extended periods of time

on irritated or damaged skin

if properties of this product change

Ask a doctor or pharmacist before use if you are

using other medications

if pregnant or nursing

When using this product

avoid contact with the eyes or mucous membranes

do not bandage tightly

supervise use by children

use caution if prone to allergies

check carefully for hypersensitivity (skin reactions)

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

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

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

Directions

Clean the affected area. Remove the paper film from the patch, and place the patch on the affected area, so that the direction of stretch is consistent with joint action.

adults and children 8 years of age and older: apply to affected area not more than 3 to 4 times daily. Do not use this product for longer than 8 hours in one day.

children under 8 years of age: do not use, consult your physician

Other information

keep tightly sealed

store at 8 to 30 C (46 to 86 F), away from sunlight

Inactive ingredients

aluminum hydroxide, capsicum, cinnamon oil, dong-quai root, erycibe (Erycibe obtusifolia Benth.) stem, fragrant angelica root, frankincense oleo-gum-resin, ginger rhizome, glycerin, kadsura pepper [Piper kadsura (Choisy) Ohwi] stem, kaolin, polyacrylic acid, san-qi ginseng root, stephania (Stephania sinica Diels.) root, titanium dioxide, turmeric rhizome, and water on a fabric backing covered with 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

Gutong Tiegao Hydrogel Pain Relieving Patch

NDC 59159-301-01

6 Patches

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

2 Patches Per Pouch
IMAGE OF CARTON

GUTONG TIEGAO PAIN RELIEVING 
camphor and menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69159-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)248 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPSICUM (UNII: 00UK7646FG)  
CINNAMON OIL (UNII: E5GY4I6YCZ)  
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
ERYCIBE OBTUSIFOLIA STEM (UNII: V1G1S38CQI)  
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
GLYCERIN (UNII: PDC6A3C0OX)  
PIPER KADSURA STEM (UNII: 80IOP41EL7)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)  
PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
HUPERZIA SERRATA (UNII: TLA53E5A4T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TURMERIC (UNII: 856YO1Z64F)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69159-301-013 in 1 BOX04/13/2016
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/13/2016
Labeler - FOSHAN AQUA GEL BIOTECH CO LTD (529128763)
Establishment
NameAddressID/FEIBusiness Operations
FOSHAN AQUA GEL BIOTECH CO LTD529128763manufacture(69159-301)
Establishment
NameAddressID/FEIBusiness Operations
GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD528565427relabel(69159-301)

Revised: 7/2018
Document Id: 6ed2325c-59c4-455b-8a40-0e583b37e645
Set id: 2fe47722-8845-4470-b844-c26f12bb325a
Version: 2
Effective Time: 20180711
 
FOSHAN AQUA GEL BIOTECH CO LTD