FDA Label for Tianhe Gutong Tiegao (in Polyisobutylene Carrier)
View Indications, Usage & Precautions
Tianhe Gutong Tiegao (in Polyisobutylene Carrier) Product Label
The following document was submitted to the FDA by the labeler of this product Guilin Tianhe Pharmaceutical Co Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients
Camphor 4%
Capsicum providing capsaicin 0.25%
Menthol 3.05%
Otc - Purpose
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
Otc - 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 changes
Otc - 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 pregnant or if prone to allergies
- check carefully for hypersensitivity (skin reactions)
- if skin becomes red and or itchy, immediately remove patch
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- using other medications
Otc - 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
- pain persists for more than 10 days
Otc - 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 2 years of age and older: apply to affected area no more than 3 to 4 times daily. Do not allow a single patch to remain in use for more than 12 hours.
- children under 2 years of age: do not use, consult your physician.
Storage And Handling
Other information
- keep tightly sealed
- store at room temperature, 15° to 30° C (59° to 86° F), away from sunlight
Inactive Ingredient
Inactive ingredients cinnamon oil, dong-quai root, erycibe (Erycibe
obtusifolia Benth.) stem, fragrant angelica root, frankincense oleo-gum-resin,
futokadsura [Kadsura heteroclita (Roxb.) Craib] stem, ginger rhizome, paraffin,
san-qi ginseng root, stephania (Stephania sinica Diels.) root, and turmeric
rhizome, in a polyisobutylene carrier covered with protective paper.
Otc - 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
Package Label.Principal Display Panel
TIANHE GUTONG TIEGAO PAIN RELIEVING PATCH NDC 68007-202-01 4 PATCHES EACH PATCH 2.75 IN X 4 IN (7 CM X 10 CM)
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