MOUTH RINSE- mentholum 0.02% menthone glycerin acetal 0.005% liquid

Mouth Rinse by

Drug Labeling and Warnings

Mouth Rinse by is a Otc medication manufactured, distributed, or labeled by Guangdong Aimu Biological Technology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

MOUTH RINSE

ACTIVE INGREDIENT

MENTHOLUM 0.02% MENTHONE GLYCERIN ACETAL 0.005%

PURPOSE

Clean the oral cavity and prevent oral diseases

INDICATIONS & USAGE

Directions:Wash your mouth for 30 secondsbefore spitting out. Do not swallow.

WARNINGS

Do not swallow, please keep out of reach of children.
For use only by people aged six and above.

DO NOT USE

Do not use under the age of six, and do not use if there is a wound in the mouth.

WHEN USING

Directions:Wash your mouth for 30 secondsbefore spitting out. Do not swallow.

STOP USE

If adverse reactions occur during use, please seek medical assistance immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Applicable population: Children over 6 years oldStorage conditions: Store in a cool and dry place,avoiding direct sunlight

STORAGE AND HANDLING

Storage conditions: Store in a cool and dry place,avoiding direct sunlight

INACTIVE INGREDIENT

WATER
CETYLPYRIDINIUM CHLORIDE
POLOXAMER 407
POTASSIUM SORBATE
SUCRALOSE
SODIUM BENZOATE
SODIUM SACCHARIN
CITRIC ACID
CI42090

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOUTH RINSE 
mentholum 0.02% menthone glycerin acetal 0.005% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.02 g  in 100 mL
MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP) (MENTHONE 1,2-GLYCEROL KETAL, (+/-)- - UNII:7QQ1EE6RCP)	MENTHONE 1,2-GLYCEROL KETAL, (+/-)-	0.005 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN (UNII: FST467XS7D)
DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-201-01	10 mL in 1 DOSE PACK; Type 0: Not a Combination Product	11/21/2023
2	NDC: 83566-201-02	12 mL in 1 CUP; Type 0: Not a Combination Product	11/21/2023
3	NDC: 83566-201-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
4	NDC: 83566-201-04	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
5	NDC: 83566-201-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
6	NDC: 83566-201-06	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
7	NDC: 83566-201-07	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
8	NDC: 83566-201-08	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
9	NDC: 83566-201-09	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
10	NDC: 83566-201-10	450 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
11	NDC: 83566-201-11	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
12	NDC: 83566-201-12	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
13	NDC: 83566-201-13	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
14	NDC: 83566-201-14	1438 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023
15	NDC: 83566-201-15	1500 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	11/21/2023

Labeler - Guangdong Aimu Biological Technology Co., Ltd (712647107)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Aimu Biological Technology Co., Ltd		712647107	manufacture(83566-201)