Storage and handling
Storage conditions: Store in a cool and dry place,avoiding direct sunlight
Mouth Rinse
- Manufacturer
- Guangdong Aimu Biological Technology Co., Ltd
- Effective date
- 2023-11-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:02:43
Label at a glance#
ProductMouth Rinse
Active ingredientMENTHOL, MENTHONE 1,2-GLYCEROL KETAL, (+/-)-
Label structure13 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
MOUTH RINSE
OTC - ACTIVE INGREDIENT SECTION
MENTHOLUM 0.02% MENTHONE GLYCERIN ACETAL 0.005%
OTC - PURPOSE SECTION
Clean the oral cavity and prevent oral diseases
INDICATIONS & USAGE SECTION
Directions:Wash your mouth for 30 secondsbefore spitting out. Do not swallow.
WARNINGS SECTION
Do not swallow, please keep out of reach of children.
For use only by people aged six and above.
OTC - DO NOT USE SECTION
Do not use under the age of six, and do not use if there is a wound in the mouth.
OTC - WHEN USING SECTION
Directions:Wash your mouth for 30 secondsbefore spitting out. Do not swallow.
OTC - STOP USE SECTION
If adverse reactions occur during use, please seek medical assistance immediately.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Applicable population: Children over 6 years oldStorage conditions: Store in a cool and dry place,avoiding direct sunlight
STORAGE AND HANDLING SECTION
Storage conditions: Store in a cool and dry place,avoiding direct sunlight
INACTIVE INGREDIENT SECTION
WATER
CETYLPYRIDINIUM CHLORIDE
POLOXAMER 407
POTASSIUM SORBATE
SUCRALOSE
SODIUM BENZOATE
SODIUM SACCHARIN
CITRIC ACID
CI42090
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83566-201-01 | Mouth Rinse | 10 mL in 1 DOSE PACK | LIQUID | 10 | 1 | |
| 83566-201-02 | Mouth Rinse | 12 mL in 1 CUP | LIQUID | 12 | 1 | |
| 83566-201-03 | Mouth Rinse | 50 mL in 1 BOTTLE | LIQUID | 50 | 1 | |
| 83566-201-04 | Mouth Rinse | 80 mL in 1 BOTTLE | LIQUID | 80 | 1 | |
| 83566-201-05 | Mouth Rinse | 100 mL in 1 BOTTLE | LIQUID | 100 | 1 | |
| 83566-201-06 | Mouth Rinse | 120 mL in 1 BOTTLE | LIQUID | 120 | 1 | |
| 83566-201-07 | Mouth Rinse | 180 mL in 1 BOTTLE | LIQUID | 180 | 1 | |
| 83566-201-08 | Mouth Rinse | 250 mL in 1 BOTTLE | LIQUID | 250 | 1 | |
| 83566-201-09 | Mouth Rinse | 300 mL in 1 BOTTLE | LIQUID | 300 | 1 | |
| 83566-201-10 | Mouth Rinse | 450 mL in 1 BOTTLE | LIQUID | 450 | 1 | |
| 83566-201-11 | Mouth Rinse | 480 mL in 1 BOTTLE | LIQUID | 480 | 1 | |
| 83566-201-12 | Mouth Rinse | 500 mL in 1 BOTTLE | LIQUID | 500 | 1 | |
| 83566-201-13 | Mouth Rinse | 1000 mL in 1 BOTTLE | LIQUID | 1000 | 1 | |
| 83566-201-14 | Mouth Rinse | 1438 mL in 1 BOTTLE | LIQUID | 1438 | 1 | |
| 83566-201-15 | Mouth Rinse | 1500 mL in 1 BOTTLE | LIQUID | 1500 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Mouth Rinse
- MENTHOLUM 0.02% MENTHONE GLYCERIN ACETAL 0.005%
- ANHYDROUS CITRIC ACID
- WATER
- MENTHOL
- MENTHONE 1,2-GLYCEROL KETAL, (+/-)-
- CETYLPYRIDINIUM CHLORIDE
- POLOXAMER 407
- POTASSIUM SORBATE
- SUCRALOSE
- SODIUM BENZOATE
- SACCHARIN
- DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83566-201 | 83566-201-01, 83566-201-02, 83566-201-03, 83566-201-04, 83566-201-05, 83566-201-06, 83566-201-07, 83566-201-08, 83566-201-09, 83566-201-10, 83566-201-11, 83566-201-12, 83566-201-13, 83566-201-14, 83566-201-15 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 0a91ce99-6b71-bc62-e063-6394a90a2bba | 0a91ce99-6b70-bc62-e063-6394a90a2bba | 2023-11-20 | Warnings | 0a91ce99-6b71-bc62-e063-6394a90a2bba 0a91ce99-6b70-bc62-e063-6394a90a2bba |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.