Label: MOUTH RINSE- mentholum 0.02% menthone glycerin acetal 0.005% liquid
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NDC Code(s):
83566-201-01,
83566-201-02,
83566-201-03,
83566-201-04, view more83566-201-05, 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
- Packager: Guangdong Aimu Biological Technology Co., Ltd
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 20, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MOUTH RINSE
mentholum 0.02% menthone glycerin acetal 0.005% liquidProduct 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)