AQUACETIC-30

Manufacturer: Aqua Medica, S.A. de C.V.
Effective date: 2025-11-10
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 01:43:02

Label at a glance#

ProductAQUACETIC-30

Active ingredientCITRIC ACID MONOHYDRATE

Label structure13 sections

Storage and handling

Store at room temperature. Keep container tightly closed when not in use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

INDUSTRIAL VINEGAR FOR THE CLEANING
OF HEMODIALYSIS MACHINES

OTC - ACTIVE INGREDIENT SECTION

Glacial Acetic Acid

OTC - PURPOSE SECTION

This product is used to descale and clean
hemodialysis machines.

INDICATIONS & USAGE SECTION

For use with 3-pump hemodialysis machines only, using purified water.

WARNINGS SECTION

Avoid contact with skin and eyes.
Do not mix with hypochlorite, or with hydrogen peroxide,
or in general with any chemical base.

OTC - DO NOT USE SECTION

Do not mix with hypochlorite, or with hydrogen peroxide,
or in general with any chemical base.

OTC - WHEN USING SECTION

Take appropriate security measures (protective clothing, glasses, masks).

OTC - STOP USE SECTION

If you do not use the entire contents, discard the excess.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

This product is used to descale and clean
hemodialysis machines.

STORAGE AND HANDLING SECTION

Store at room temperature.

Keep container tightly closed when not in use.

INACTIVE INGREDIENT SECTION

Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AQUACETIC-30 LABEL81943-801-01

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81943-801-01	2024-11-18	C162847	48780-1	1030e365-4bc3-111a-e063-dadaa90a10e2	040775ab-41bd-cd36-e063-6394a90a08aa
81943-801-01	2024-11-18	C162847	48780-1	1030e365-4bc3-111a-e063-dadaa90a10e2	040775ab-41bd-cd36-e063-6394a90a08aa
81943-801-01	2024-07-30	C162847	48780-1	1030e365-4bc3-111a-e063-dadaa90a10e2	040775ab-41bd-cd36-e063-6394a90a08aa
81943-801-01	2024-07-30	C162847	48780-1	1030e365-4bc3-111a-e063-dadaa90a10e2	040775ab-41bd-cd36-e063-6394a90a08aa
81943-801-01	2024-01-30	C162847	48780-1	1030e365-4bc3-111a-e063-dadaa90a10e2	040775ab-41bd-cd36-e063-6394a90a08aa
81943-801-01	2024-01-30	C162847	48780-1	1030e365-4bc3-111a-e063-dadaa90a10e2	040775ab-41bd-cd36-e063-6394a90a08aa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81943-801-01	AQUACETIC-30	3785 mL in 1 BOTTLE	SOLUTION, CONCENTRATE	3785		3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

AQUACETIC-30
Cleaning Solution for Hemodialysis Machines
CITRIC ACID MONOHYDRATE
ANHYDROUS CITRIC ACID
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
81943-801	81943-801-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	ACTIM
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2024-11-18	full-release	2026-06-01 00:37:43

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AQUACETIC-30	CLEANING SOLUTION FOR HEMODIALYSIS MACHINES	Aqua Medica, S.A. de C.V.	040775ab-41bd-cd36-e063-6394a90a08aa	2025-11-10	Warnings	Exact identifier ndc (package): 81943-801-01 ndc (product): 81943-801 ndc11 (package): 81943080101 spl id: 43485fb0-f129-7198-e063-6294a90afcde spl set id: 040775ab-41bd-cd36-e063-6394a90a08aa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.