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| Product NDC Code | 84445-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Tinnitus relinf patches |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TRANSDERMAL | ||||
| Dosage Form | PATCH | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Shenzhen Furuizhilian keji Co., Ltd. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Camphor 3% Borneol 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Adults and children 12 years of age and over: ■ clean and dry affected area ■ remove patch from film ■ apply to affected area not more than 3 to 4 times daily ■ remove patch from the skin after at most8-hour application Children under 12 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Artemisia Argyi Leaf Extract, Scutellaria Baicalensis Extract, Poria Cocos Extract, Atractylodes Macrocephala Root Extract, Tangerine Peel, Magnolia Bark Extract
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.For temporary relief of minor aches & pains of muscles & joints associated with: arthritis, simple backache, strains, bruises, sprains
Purpose
Information about the drug product’s indications for use.Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.TINNITUS RELINF PATCHES Camphor, Borneol ATRACTYLODES MACROCEPHALA ROOT TANGERINE PEEL CAMPHOR, (-)- CAMPHOR, (-)- SCUTELLARIA BAICALENSIS ROOT ARTEMISIA ARGYI LEAF FU LING MAGNOLIA OBOVATA BARK BORNEOL BORNEOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.label
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.on damaged skin with a heating pad if you are allergic to any ingredients of this product
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.■ skin reactions such as redness, itching, rash, excessive irritation,burning sensation, swelling or blistering occur ■ symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.use only as directed avoid contact with the eyes, mucous membranes or rashes. do not bandage tightly
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API