AQUACETIC-30- cleaning solution for hemodialysis machines solution, concentrate

AQUACETIC-30 by

Drug Labeling and Warnings

AQUACETIC-30 by is a Otc medication manufactured, distributed, or labeled by AQUA MEDICA, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

INDUSTRIAL VINEGAR FOR THE CLEANING
OF HEMODIALYSIS MACHINES

ACTIVE INGREDIENT

Glacial Acetic Acid

PURPOSE

This product is used to descale and clean
hemodialysis machines.

INDICATIONS & USAGE

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

WARNINGS

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

DO NOT USE

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

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

This product is used to descale and clean
hemodialysis machines.

STORAGE AND HANDLING

Store at room temperature.

Keep container tightly closed when not in use.

INACTIVE INGREDIENT

Water.

PRINCIPAL DISPLAY PANEL

81943-801-01

INGREDIENTS AND APPEARANCE

AQUACETIC-30 
cleaning solution for hemodialysis machines solution, concentrate

Product 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)