CITRACID-50- desinfectant solution for hemodialysis machine 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 product is used to descale and desinfect Hemodialysis machines.

Citric Acid

For use with 3-pump hemodialysis machines only.

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

Avoid contact with skin an eyes.

Irritation hazard if spilled or splashed.

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

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

Wash splashes on skin or clothing with plenty of water.

If 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.

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

Store at room temperature.

Keep container tightly closed when not in use.

Water.

CITRACID-50 LABEL

CITRACID-50 
desinfectant solution for hemodialysis machine solution, concentrate
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-701
Route of AdministrationHEMODIALYSIS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.5 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81943-701-015000 mL in 1 CONTAINER; 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(81943-701)

Revised: 8/2023
Document Id: 040713e7-67ce-8eb0-e063-6394a90aa2a9
Set id: 040713e7-67cd-8eb0-e063-6394a90aa2a9
Version: 1
Effective Time: 20230828
 
AQUA MEDICA, S.A. DE C.V.