MOUTH RINSE- mentholum 0.02% menthone glycerin acetal 0.005% liquid 
Guangdong Aimu Biological Technology Co., Ltd

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MOUTH RINSE

MOUTH RINSE

MENTHOLUM 0.02% MENTHONE GLYCERIN ACETAL 0.005%

Clean the oral cavity and prevent oral diseases

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

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

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

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

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

Keep out of reach of children.

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

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

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

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MOUTH RINSE 
mentholum 0.02% menthone glycerin acetal 0.005% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83566-201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.02 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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83566-201-0110 mL in 1 DOSE PACK; Type 0: Not a Combination Product11/21/2023
2NDC:83566-201-0212 mL in 1 CUP; Type 0: Not a Combination Product11/21/2023
3NDC:83566-201-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
4NDC:83566-201-0480 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
5NDC:83566-201-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
6NDC:83566-201-06120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
7NDC:83566-201-07180 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
8NDC:83566-201-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
9NDC:83566-201-09300 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
10NDC:83566-201-10450 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
11NDC:83566-201-11480 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
12NDC:83566-201-12500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
13NDC:83566-201-131000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
14NDC:83566-201-141438 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
15NDC:83566-201-151500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02111/21/2023
Labeler - Guangdong Aimu Biological Technology Co., Ltd (712647107)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Aimu Biological Technology Co., Ltd712647107manufacture(83566-201)

Revised: 11/2023
Document Id: 0a91ce99-6b71-bc62-e063-6394a90a2bba
Set id: 0a91ce99-6b70-bc62-e063-6394a90a2bba
Version: 1
Effective Time: 20231120
 
Guangdong Aimu Biological Technology Co., Ltd