FDA.reportPublic FDA data

HOUKEA Tinnitus Relief Nasal Inhaler

Manufacturer
Guangdong Ximonth Technology Co., Ltd.
Effective date
2024-10-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:32:37

Label at a glance#

ProductHOUKEA Tinnitus Relief Nasal Inhaler
Active ingredientWITCH HAZEL, MENTHA PIPERITA LEAF, TARAXACUM OFFICINALE, ARTEMISIA VULGARIS ROOT
Label structure10 sections

Storage and handling

Store in a cool and dry place.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

TARAXACUM OFFICINALE、MENTHA PIPERITA LEAF、ARTEMISIA VULGARIS ROOT、WITCH HAZEL

Purpose

OTC - PURPOSE SECTION

Relieves ear irritation and itching; improves hearing and increases comfort; helps relieve anxiety associated with tinnitus.

Use

OTC - WHEN USING SECTION

1.Open the lid.
2. Place this product under the nostrils.
3. Inhale slowly for 5 seconds and then exhale slowly for relief.

Warnings

WARNINGS SECTION

Please keep out of reach of children.Do not swallow.Please clean your hands before use to ensure the best results from the product.Discontinue use if signs of irritation or rash occur.Store in a cool and dry place.

Do not use

OTC - DO NOT USE SECTION

Discontinue use if signs of irritation or rash occur.

Stop Use

OTC - STOP USE SECTION

Discontinue use if signs of irritation or rash occur.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please keep out of reach of children. Do not swallow.

STORAGE AND HANDLING SECTION

Store in a cool and dry place.

INACTIVE INGREDIENT SECTION

GLYCERIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84660-097-01HOUKEA Tinnitus Relief Nasal Inhaler1.8 mg in 1 BOXCREAM1.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84660-097HOUKEA TINNITUS RELIEF NASAL INHALER (GLYCERIN) CREAM [GUANGDONG XIMONTH TECHNOLOGY CO., LTD.]11 package rows20241102_25d1312b-320f-c28b-e063-6394a90a6da1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84660-09784660-097-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WITCH HAZEL101I4J0U34ACTIB
MENTHA PIPERITA LEAFA389O33LX6ACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
GLYCERINPDC6A3C0OXIACT
ARTEMISIA VULGARIS ROOT32MP823R8SACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
25d1312b-3210-c28b-e063-6394a90a6da125d1312b-320f-c28b-e063-6394a90a6da12024-10-31WarningsExact identifier
spl id: 25d1312b-3210-c28b-e063-6394a90a6da1
spl set id: 25d1312b-320f-c28b-e063-6394a90a6da1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.