SPL v7
SPL
SPL Set ID c3c1da3a-abad-383c-e053-2a95a90a1a4f
Route
HEMODIALYSIS
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorate Ion (0.167 g)
Inactive Ingredients
Magnesium Chloride Calcium Chloride Acetic Acid C-11 Dextrose Water Sodium Chloride

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-03-30
Description

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.

Purpose

For use with 3-pump hemodialysis machines only.

Medication Information

Purpose

For use with 3-pump hemodialysis machines only.

Description

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.

Use

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

Section 42229-5

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.

Section 43683-2

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

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

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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.

Warnings

For use with 3-pump hemodialysis machines only.

Directions
  • By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).
Do Not Use
  • If the warranty seal is damaged or broken and do not allow debris to fall into the concentrate.
Other Information
  • Store at room temperature.
Active Ingredient(s)

Potassium Chloride

Inactive Ingredients

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

Package Label Principal Display Panel

3785 mL NDC: 81943-604-02

Structured Label Content

Use

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

Section 42229-5 (42229-5)

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.

Section 43683-2 (43683-2)

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

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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.

Purpose

For use with 3-pump hemodialysis machines only.

Warnings

For use with 3-pump hemodialysis machines only.

Directions
  • By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).
Do Not Use (Do not use)
  • If the warranty seal is damaged or broken and do not allow debris to fall into the concentrate.
Other Information (Other information)
  • Store at room temperature.
Active Ingredient(s)

Potassium Chloride

Inactive Ingredients (Inactive ingredients)

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

Package Label Principal Display Panel (Package Label - Principal Display Panel)

3785 mL NDC: 81943-604-02

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:27.504555 · Updated: 2026-03-14T23:13:34.159935