AQUACID-220- acid concentrate for hemodialysis solution, concentrate 
AQUA MEDICA, S.A. DE C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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This is a Hemodialysis Acid Concentrate, Pyrogen-Free.

By diluiting one part of this acid concentrate with 34 parts of purified water (ISO Standard 13959:2014), each 1000 ml of this solucion provides:

Sodium: 103.00 mEq/l

Potassium: 0.00 mEq/l

Calcium: 2.50 mEq/l

Magnesium: 1.00 mEq/l

Chlorides: 106.50 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

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

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

  • By diluting one part of this acid concentrate with 34 parts of purified water (ISO Standard 13959:2014).

Other information

  • Store at room temperature.
  • If you do not use the entire contents, discard the excess.

Inactive ingredients

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

Package Label - Principal Display Panel

3785 mL NDC: 81943-602-04 3785 mL Label

AQUACID-220 
acid concentrate for hemodialysis solution, concentrate
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-602
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
SODIUM CHLORIDE (UNII: 451W47IQ8X) 21.07 g  in 100 mL
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) 0.631 g  in 100 mL
DEXTROSE (UNII: IY9XDZ35W2) 3.5 g  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81943-602-043785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/30/2020
Labeler - AQUA MEDICA, S.A. DE C.V. (816672224)
Establishment
NameAddressID/FEIBusiness Operations
AQUA MEDICA, S.A. DE C.V.816672224manufacture(81943-602)

Revised: 11/2022
 
AQUA MEDICA, S.A. DE C.V.