SPL v7
SPL
SPL Set ID c3cd1703-ced5-114a-e053-2995a90a4db3
Route
HEMODIALYSIS
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorate Ion (26.3 g)
Inactive Ingredients
Sodium Chloride Acetic Acid C-11 Dextrose Water Magnesium Chloride Calcium 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: 100.00 mEq/l Potassium: 0.00 mEq/l Calcium: 3.00 mEq/l Magnesium: 0.75 mEq/l Chlorides: 103.75 mEq/l Acetate: 4.00 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: 100.00 mEq/l Potassium: 0.00 mEq/l Calcium: 3.00 mEq/l Magnesium: 0.75 mEq/l Chlorides: 103.75 mEq/l Acetate: 4.00 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: 100.00 mEq/l

Potassium: 0.00 mEq/l

Calcium: 3.00 mEq/l

Magnesium: 0.75 mEq/l

Chlorides: 103.75 mEq/l

Acetate: 4.00 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.
  • Keep container tightly closed when not in use.
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: 81943-603-03

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: 100.00 mEq/l

Potassium: 0.00 mEq/l

Calcium: 3.00 mEq/l

Magnesium: 0.75 mEq/l

Chlorides: 103.75 mEq/l

Acetate: 4.00 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.
  • Keep container tightly closed when not in use.
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: 81943-603-03

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:27.505746 · Updated: 2026-03-14T23:13:34.159935