Otc - Active Ingredient
Camphor 0.01%
Borneol 0.01%
Tinnitus Relinf Patches
FDA Label NDC 84575-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Linhe Biotechnology (shenzhen) Co., Ltd for the product Tinnitus Relinf Patches (NDC 84575-002). 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 8 joints associated with arthritis, simple backache, strains, bruises, sprains
Warnings
For external use only
Otc - Do Not Use
1.on damaged skin. 2.with a heating pad. 3.if you are allergic to any ingredients of this product.
Otc - When Using
1.use only as directed. 2.avoid contact with the eyes, mucous membranes or rashes. 3.do not bandage tightly.
Otc - Stop Use
1.skin reactions such as redness, itching, rash, excessive irritation,burning sensation,sweling or blistering occur, 2.symptoms persist for more than 7 days. 3.symptoms clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
lf swallowed, get medical help or contact a Poison Control center right away.
Dosage & Administration
Adults and children 12 years of age and over:
1.clean and dry affected area. 2.remove patch from film. 3.opply to affected area not morethan 3 to f times daily. 4.remove patch from the skin after at most 8-hour application.
Children under 12 years of age:
Cansult a doctor.
Inactive Ingredient
Fu Ling
Package Label.Principal Display Panel
Label (A9mvl Dyshq)
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