AQUACID-120- acid concentrate for hemodialysis solution, concentrate

AQUACID-120 by

Drug Labeling and Warnings

AQUACID-120 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

This is a Hemodialysis Acid Concentrate, Pyrogen-Free.

By diluiting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014), each 1000 ml of this solucion provides:

Sodium: 130.00 mEq/l

Potassium: 2.00 mEq/l

Calcium: 2.50 mEq/l

Magnesium: 1.00 mEq/l

Chlorides: 108.50 mEq/l

Acetate: 3.00 mEq/l

Dextrose: 100.00 mEq/l

The final conductivity calculated at 25 C is 13.2 to 14.2 mS/cm.

Active Ingredient(s)

Potassium Chloride

Purpose

For use with 3-pump hemodialysis machines only.

Use

For use with 3-pump hemodialysis machines only, using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.

Warnings

For use with 3-pump hemodialysis machines only.

Do not use

• If the warranty seal is damaged or broken and do not allow debris to fall into the concentrate.

WHEN USING

Using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.

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

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.

Directions

• By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).

Inactive ingredients

Sodium chloride, calcium chloride, acetic acid, dextrose, purified water USP

Other information

• Store at room temperature.

Package Label - Principal Display Panel

3785 mL NDC: 81943-604-02

INGREDIENTS AND APPEARANCE

AQUACID-120 
acid concentrate for hemodialysis solution, concentrate

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81943-604
Route of Administration	HEMODIALYSIS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM CHLORATE (UNII: H35KS68EE7) (CHLORATE ION - UNII:08Z8093742)	POTASSIUM CHLORATE	0.671 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)	0.167 g  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)	0.486 g  in 100 mL
ACETIC ACID C-11 (UNII: 2A9OM7IPNW)	0.361 g  in 100 mL
DEXTROSE (UNII: IY9XDZ35W2)	3.5 g  in 100 mL
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)	21.07 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81943-604-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/30/2020

Labeler - Aqua Medica, S.A. de C.V. (589696442)

Establishment
Name	Address	ID/FEI	Business Operations
Aqua Medica, S.A. de C.V.		589696442	manufacture(81943-604)