Otc - Active Ingredient
CYNOMORIUM SONGARICUM STEM
Tinnitus Patch
FDA Label NDC 52784-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhengzhou Giant Biochemistry Group Co.,ltd for the product Tinnitus Patch (NDC 52784-030). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, storage and handling, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Easy to Useļ¼Relieve Insomnia
Suitable for All Kinds of Ear Problems
Highly Permeable Ear-ringing Deeper Relief Tinnitus
Solve tinnitus,auditory hallucinations and other hearing impairments
Otc - Keep Out Of Reach Of Children
Children must use it under the supervision of adults
Indications & Usage
lt has the health care function of nourishing gi and blood, nourishing liver and kidney; lt is suitable for the sub-healthy people who suffer from local discomfort caused by dizziness and tinnitus such as cicadas.
Warnings
1 . This product is for external use. lt is forbidden to take orally.
2. It is forbidden for pregnant women and those who are allergic to this product, and should be used with caution for those with allergic constitution.
3. lt is forbidden to paste on the skin with ulceration, damage and infection.
4. For foreign bodies in the external auditory canal, you should go to the hospital.
5. Children must use it under the supervision of adults.
6. This product is a health care product and cannot replace drugs and medical devices.
Dosage & Administration
Respectively clean the front and back of the ear skin, dry, open the packaging, remove the backing paper,paste paste on the skin, each stick 4 ~ 8 hours, once a day, 15 days for a cycle.
Storage And Handling
Sealed and stored in a dry and dark place with good ventilation and room temperature.
[Shelf Life] 36 months
Otc - Do Not Use
1 . This product is for external use. lt is forbidden to take orally.
2. It is forbidden for pregnant women and those who are allergic to this product, and should be used with caution for those with allergic constitution.
Inactive Ingredient
POLYGONATI RHIZOMA
HIPPOCAMPUS
CNIDII FRUCTUS
ASTRAGALI RADIX
CISTANCHES HERBA
TAMARICIS CACUMEN
GANODERMA
NOTOGINSENG RADIX ET RHIZOMA
CARTHAMI FLOS
DENDROBII CAULIS
CURCUMAE RHIZOMA
EUODIAE FRUCTUS
CYNANCHI PANICULATI RADLXET RHIZOMA
ACONITI LATERAKIS RADIX PRAEPARATA
GENTIANAE MACROPHYLLAE RADIX
ACANTHOPANACIS CORTEX
LAUROCAPRAM
Package Label.Principal Display Panel
Label (Label)
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