AQUACID-120- acid concentrate for hemodialysis solution, concentrate 
AQUA MEDICA, S.A. DE C.V.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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.

Active Ingredient(s)

Potassium Chloride

Purpose

For use with 3-pump hemodialysis machines only.

Use

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

Warnings

For use with 3-pump hemodialysis machines only.

Do not use

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.

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

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

Directions

Inactive ingredients

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

Other information

Package Label - Principal Display Panel

3785 mL Label3785 mL NDC: 81943-604-02

AQUACID-120 
acid concentrate for hemodialysis solution, concentrate
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-604
Route of AdministrationHEMODIALYSIS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM CHLORATE (UNII: H35KS68EE7) (CHLORATE ION - UNII:08Z8093742) POTASSIUM CHLORATE0.671 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) 0.167 g  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 0.486 g  in 100 mL
ACETIC ACID C-11 (UNII: 2A9OM7IPNW) 0.361 g  in 100 mL
DEXTROSE (UNII: IY9XDZ35W2) 3.5 g  in 100 mL
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X) 21.07 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81943-604-023785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/30/2020
Labeler - AQUA MEDICA, S.A. DE C.V. (816672224)
Establishment
NameAddressID/FEIBusiness Operations
AQUA MEDICA, S.A. DE C.V.816672224manufacture(81943-604)

Revised: 10/2023
Document Id: 090c13a7-e58e-ae0d-e063-6294a90a720d
Set id: c3c1da3a-abad-383c-e053-2a95a90a1a4f
Version: 5
Effective Time: 20231031
 
AQUA MEDICA, S.A. DE C.V.