DailyMed - DailyMed Details

SPL v3

SPL

SPL Set ID 040713e7-67cd-8eb0-e063-6394a90aa2a9

Route

HEMODIALYSIS

Published

Effective Date 2023-03-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Anhydrous Citric Acid (0.5 g)

Inactive Ingredients

Water

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2023-03-30

Description

This product is used to descale and desinfect Hemodialysis machines.

Medication Information

Warnings and Precautions

Avoid contact with skin an eyes.

Irritation hazard if spilled or splashed.

Indications and Usage

For use with 3-pump hemodialysisi machines only, using purified water (StandardUNE-EN ISO 23500-3:2019).

Dosage and Administration

By diluting one part of this acid concentrate with one part of purified water.

Description

This product is used to descale and desinfect Hemodialysis machines.

Section 42229-5

This product is used to descale and desinfect Hemodialysis machines.

Section 44425-7

Store at room temperature.

Keep container tightly closed when not in use.

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 do not use the entire contents, discard the excess.

Section 50567-7

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

Wash splashes on skin or clothing with plenty of water.

Section 50570-1

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

Section 51727-6

Water.

Section 51945-4

Section 55105-1

For use with 3-pump hemodialysis machines only.

Section 55106-9

Citric Acid

Structured Label Content

Indications and Usage (34067-9)

For use with 3-pump hemodialysisi machines only, using purified water (StandardUNE-EN ISO 23500-3:2019).

Dosage and Administration (34068-7)

By diluting one part of this acid concentrate with one part of purified water.

Warnings and Precautions (34071-1)

Avoid contact with skin an eyes.

Irritation hazard if spilled or splashed.

Section 42229-5 (42229-5)

This product is used to descale and desinfect Hemodialysis machines.

Section 44425-7 (44425-7)

Store at room temperature.

Keep container tightly closed when not in use.

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 do not use the entire contents, discard the excess.

Section 50567-7 (50567-7)

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

Wash splashes on skin or clothing with plenty of water.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For use with 3-pump hemodialysis machines only.

Section 55106-9 (55106-9)

Citric Acid

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "ACTIM", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For use with 3-pump hemodialysisi machines only, using purified water (StandardUNE-EN ISO 23500-3:2019).", "34068-7": "By diluting one part of this acid concentrate with one part of purified water.", "34071-1": "Avoid contact with skin an eyes. Irritation hazard if spilled or splashed.", "42229-5": "This product is used to descale and desinfect Hemodialysis machines.", "44425-7": "Store at room temperature. Keep container tightly closed when not in use.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "If do not use the entire contents, discard the excess.", "50567-7": "Take appropriate security measures (protective clothing, glasses, masks). Wash splashes on skin or clothing with plenty of water.", "50570-1": "If the warranty seal is damaged or broken and do not allow debris to fall into the concentrate.", "51727-6": "Water.", "55105-1": "For use with 3-pump hemodialysis machines only.", "55106-9": "Citric Acid"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:26.851348 · Updated: 2026-03-14T23:13:32.363247