GUTONG TIEGAO PAIN RELIEVING- camphor and menthol patch

GUTONG TIEGAO PAIN RELIEVING by

Drug Labeling and Warnings

GUTONG TIEGAO PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by FOSHAN AQUA GEL BIOTECH CO LTD, GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Camphor 3.1%

Menthol 1.25%

PURPOSE

Purpose

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

DO NOT USE

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

using other medications

if pregnant or nursing

WHEN USING

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

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

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

keep tightly sealed

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

INACTIVE INGREDIENT

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

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

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

INGREDIENTS AND APPEARANCE

GUTONG TIEGAO PAIN RELIEVING 
camphor and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69159-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	248 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69159-301-01	3 in 1 BOX	04/13/2016
1		2 in 1 POUCH; 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	04/13/2016

Labeler - FOSHAN AQUA GEL BIOTECH CO LTD (529128763)

Establishment
Name	Address	ID/FEI	Business Operations
FOSHAN AQUA GEL BIOTECH CO LTD		529128763	manufacture(69159-301)

Establishment
Name	Address	ID/FEI	Business Operations
GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD		528565427	relabel(69159-301)