CITRACID-50- desinfectant solution for hemodialysis machine solution, concentrate

CITRACID-50 by

Drug Labeling and Warnings

CITRACID-50 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 product is used to descale and desinfect Hemodialysis machines.

ACTIVE INGREDIENT

Citric Acid

PURPOSE

For use with 3-pump hemodialysis machines only.

INDICATIONS & USAGE

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

WARNINGS

Avoid contact with skin an eyes.

Irritation hazard if spilled or splashed.

DO NOT USE

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

WHEN USING

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

Wash splashes on skin or clothing with plenty of water.

STOP USE

If 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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Store at room temperature.

Keep container tightly closed when not in use.

INACTIVE INGREDIENT

Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CITRACID-50 
desinfectant solution for hemodialysis machine solution, concentrate

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81943-701
Route of Administration	HEMODIALYSIS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	0.5 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81943-701-01	5000 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/30/2023

Labeler - AQUA MEDICA, S.A. DE C.V. (816672224)

Establishment
Name	Address	ID/FEI	Business Operations
AQUA MEDICA, S.A. DE C.V.		816672224	manufacture(81943-701)