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GUTONG TIEGAO PAIN RELIEVING by FOSHAN AQUA GEL BIOTECH CO LTD

Medically reviewed on April 18, 2018

Dosage form: patch
Ingredients: CAMPHOR (SYNTHETIC) 248mg, MENTHOL 100mg
Labeler: FOSHAN AQUA GEL BIOTECH CO LTD
NDC Code: 69159-301

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 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

GUTONG TIEGAO PAIN RELIEVING 
camphor and menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69159-301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)248 mg
MENTHOL (MENTHOL) MENTHOL100 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
CAPSICUM 
CINNAMON OIL 
ANGELICA SINENSIS ROOT 
ERYCIBE OBTUSIFOLIA STEM 
ANGELICA DAHURICA ROOT 
FRANKINCENSE 
ZINGIBER OFFICINALE WHOLE 
GLYCERIN 
PIPER KADSURA STEM 
KAOLIN 
POLYACRYLIC ACID (800000 MW) 
PANAX NOTOGINSENG ROOT 
HUPERZIA SERRATA 
TITANIUM DIOXIDE 
TURMERIC 
WATER 
Packaging
#Item CodePackage Description
1NDC:69159-301-013 POUCH in 1 BOX
12 PATCH in 1 POUCH
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/FEIOperations
FOSHAN AQUA GEL BIOTECH CO LTD529128763repack(69159-301)
Establishment
NameAddressID/FEIOperations
GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD528565427manufacture(69159-301)

 
FOSHAN AQUA GEL BIOTECH CO LTD

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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