Otc - Active Ingredient
Camphor 3%
Borneol 4%
Tinnitus Relinf Patches
FDA Label NDC 84445-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Furuizhilian Keji Co., Ltd. for the product Tinnitus Relinf Patches (NDC 84445-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Indications & Usage
For temporary relief of minor aches & pains of muscles & joints associated with: arthritis, simple backache, strains, bruises, sprains
Warnings
For external use only
Otc - Do Not Use
on damaged skin
with a heating pad
if you are allergic to any ingredients of this product
Otc - When Using
use only as directed
avoid contact with the eyes, mucous membranes or rashes.
do not bandage tightly
Otc - Stop Use
■ 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
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
Artemisia Argyi Leaf Extract, Scutellaria Baicalensis Extract, Poria Cocos Extract, Atractylodes Macrocephala Root Extract, Tangerine Peel, Magnolia Bark Extract
Package Label.Principal Display Panel
Label (L262196169)
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