Label: AQUACETIC-30- cleaning solution for hemodialysis machines solution, concentrate
- NDC Code(s): 81943-801-01
- Packager: AQUA MEDICA, S.A. DE C.V.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated August 28, 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
AQUACETIC-30
cleaning solution for hemodialysis machines solution, concentrateProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81943-801 Route of Administration HEMODIALYSIS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 0.7 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81943-801-01 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 03/30/2023 Labeler - AQUA MEDICA, S.A. DE C.V. (816672224) Establishment Name Address ID/FEI Business Operations AQUA MEDICA, S.A. DE C.V. 816672224 manufacture(81943-801)