CITRACID-50

Manufacturer
Aqua Medica, S.A. de C.V.
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:43:02

Label at a glance#

ProductCITRACID-50
Active ingredientCITRIC ACID MONOHYDRATE
Label structure13 sections

Storage and handling

Store at room temperature. Keep container tightly closed when not in use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This product is used to descale and desinfect Hemodialysis machines.

OTC - ACTIVE INGREDIENT SECTION

Citric Acid

OTC - PURPOSE SECTION

For use with 3-pump hemodialysis machines only.

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Avoid contact with skin an eyes.

Irritation hazard if spilled or splashed.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

Wash splashes on skin or clothing with plenty of water.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at room temperature.

Keep container tightly closed when not in use.

INACTIVE INGREDIENT SECTION

Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CITRACID-50 LABELCITRACID-50 LABEL

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81943-701-01CITRACID-505000 mL in 1 CONTAINERSOLUTION, CONCENTRATE50003

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81943-70181943-701-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-11-18full-release2026-06-01 00:37:43

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CITRACID-50DESINFECTANT SOLUTION FOR HEMODIALYSIS MACHINEAqua Medica, S.A. de C.V.040713e7-67cd-8eb0-e063-6394a90aa2a92025-11-10WarningsExact identifier
ndc (package): 81943-701-01
ndc (product): 81943-701
ndc11 (package): 81943070101
spl id: 43486bf7-f87e-f437-e063-6394a90a338c
spl set id: 040713e7-67cd-8eb0-e063-6394a90aa2a9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.