AQUACID-100- 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: 100.00 mEq/l

Potassium: 2.00 mEq/l

Calcium: 3.00 mEq/l

Magnesium: 0.75 mEq/l

Chlorides: 105.75 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.

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

Other information

Inactive ingredients

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

Package Label - Principal Display Panel

3785 mL Label3785 mL NDC: 81943-605-01

AQUACID-100 
acid concentrate for hemodialysis solution, concentrate
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-605
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) 0.161 g  in 100 mL
ACETIC ACID C-11 (UNII: 2A9OM7IPNW) 1.08 g  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 0.749 g  in 100 mL
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X) 24.3 g  in 100 mL
DEXTROSE (UNII: IY9XDZ35W2) 4.5 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81943-605-013785 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(81943-605)

Revised: 10/2023
Document Id: 090c0f11-97ae-bb1b-e063-6294a90a07ee
Set id: c3c087ef-0efd-2ef8-e053-2995a90af189
Version: 6
Effective Time: 20231031
 
AQUA MEDICA, S.A. DE C.V.