AQUACETIC-30- cleaning solution for hemodialysis machines 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.

----------

INDUSTRIAL VINEGAR FOR THE CLEANING
OF HEMODIALYSIS MACHINES

Glacial Acetic Acid

This product is used to descale and clean
hemodialysis machines.

For use with 3-pump hemodialysis machines only, using purified water.

Avoid contact with skin and eyes.
Do not mix with hypochlorite, or with hydrogen peroxide,
or in general with any chemical base.

Do not mix with hypochlorite, or with hydrogen peroxide,
or in general with any chemical base.

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

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.

This product is used to descale and clean
hemodialysis machines.

Store at room temperature.

Keep container tightly closed when not in use.

Water.

AQUACETIC-30 LABEL81943-801-01

AQUACETIC-30 
cleaning solution for hemodialysis machines solution, concentrate
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-801
Route of AdministrationHEMODIALYSIS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.7 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81943-801-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/30/2023
Labeler - AQUA MEDICA, S.A. DE C.V. (816672224)
Establishment
NameAddressID/FEIBusiness Operations
AQUA MEDICA, S.A. DE C.V.816672224manufacture(81943-801)

Revised: 8/2023
Document Id: 040775ab-41be-cd36-e063-6394a90a08aa
Set id: 040775ab-41bd-cd36-e063-6394a90a08aa
Version: 1
Effective Time: 20230828
 
AQUA MEDICA, S.A. DE C.V.