OTC - ACTIVE INGREDIENT SECTION
Active ingredient: Menthol 5g/100g
Rotosxika Tinnitus Relief Patch
- Manufacturer
- Puning Xinhua Trade Co., Ltd. | Nanyang Jingzhilan Biotechnology Co., Ltd.
- Effective date
- 2023-10-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:57:24
Label at a glance#
ProductRotosxika Tinnitus Relief Patch
Active ingredientMENTHOL
Label structure10 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose: Relieve tinnitus
INDICATIONS & USAGE SECTION
Indication:
Helps alleviate symptoms of tinnitus.
DOSAGE & ADMINISTRATION SECTION
Directions:
For external use,remove the antisticking paper,apply the plaster to the Yongquan point on the feet or behind the ears for 8-12 hours each time.
WARNINGS SECTION
Precautions
1.This product is an external product, do not take it internally;
2.This product is a health careproduct and does not replace drugs and medical devices for treatment;
3.Pregnant women, infants, breastfeeding, and those allergic to this product are prohibited;
4.Do not use skin allergies, skin damage, skin diseases and other symptoms;
5.If the skin appears red, itchy and other abnormal conditions during use, please suspend use.
OTC - QUESTIONS SECTION
Questions or comments? +8617846992567
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Frankincense myrrh.
STATEMENT OF IDENTITY SECTION
Other information:
Sealed packaging, please keep in a cool and dark place.
Produced by:
Nanyang Jingzhilan Biotechnology Co.,Ltd
No.6,Road 2,Longsheng Industrial Park,Wangcun Township, Wolong District,Nanyang City
OEM Company: Puning Xinhua Trade Co.,Ltd
Made in China
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Same as WARNINGS SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Label
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83702-018-12 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-80b1-d83d-e063-dadaa90ab31f | Tinnitus Relief Patch-83702-018-12 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83702-018-11 | Rotosxika Tinnitus Relief Patch | 2.1 g in 1 PATCH | PATCH | 2.1 | 1 | |
| 83702-018-12 | Rotosxika Tinnitus Relief Patch | 12 in 1 BAG | PATCH | 12 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Rotosxika Tinnitus Relief Patch
- Menthol
- FRANKINCENSE
- MYRRH
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83702-018 | 83702-018-11, 83702-018-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| FRANKINCENSE | R9XLF1R1WM | IACT |
| MYRRH | JC71GJ1F3L | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 08106f34-d0bd-a18d-e063-6394a90a08b9 | 08106f34-d0bc-a18d-e063-6394a90a08b9 | 2023-10-19 | Warnings | 08106f34-d0bd-a18d-e063-6394a90a08b9 08106f34-d0bc-a18d-e063-6394a90a08b9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.