AQUATEC ALONGLIFE- chelated copper sulfate pentahydrate solution 
GRUPO TMA TECNOLOGIAS PARA EL MEJORAMIENTO DEL AGUA 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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AQUATEC SOLUTION ALONGLIFE SANITIZER

ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

Active ingredient Chelated Copper Sulfate Pentahydrate .02475 %

PURPOSE

Purpose Antmicrobial, Bactericide, Virucidal

INDICATION AND USAGE

Use[s]

Skin, objects and surface sanitizer to help reduce bacteria and viruses

DOSAGE AND ADMINISTRATION

Directions

Place enough product on skin, objects and surfaces to cover all surface. This product is food grade. Supervise children under 6 years of age.

WARNINGS AND PRECAUTIONS

AQUATEC should only be mixed with water. For external use only. Don not ingest, avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNINGS

Warnings

For external use only.

AQUATEC should only be mixed with water. For external use only. Don not ingest, avoid contact with eyes.

INACTIVE INGREDIENTS

Inactive ingredients: Purified demineralized water, Zinc Chelate

DO NOT USE

In children less than 2 months of age.

PACKAGE LABEL

AQUATEC LABEL 20000 mlAQUATEC LABEL 10000 mlAQUATEC LABE 5000 mlAQUATEC LABEL 240mlAQUATEC LABEL 120mlAquatec etiqueta eng FDA 60ml.jpgAquatec Label 490 ml eng FINAL.jpgAquatec Label 990 ml eng FINAL.jpg

AQUATEC ALONGLIFE 
chelated copper sulfate pentahydrate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80224-1000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION0.02475 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.975125 mL  in 1 mL
ZINC (UNII: J41CSQ7QDS) 0.000125 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80224-1000-5490 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
2NDC:80224-1000-61000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
3NDC:80224-1000-75000 mL in 1 JUG; Type 0: Not a Combination Product08/26/2020
4NDC:80224-1000-810000 mL in 1 JUG; Type 0: Not a Combination Product08/26/2020
5NDC:80224-1000-920000 mL in 1 JUG; Type 0: Not a Combination Product08/26/2020
6NDC:80224-1000-160 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
7NDC:80224-1000-2120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
8NDC:80224-1000-3240 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/26/2020
Labeler - GRUPO TMA TECNOLOGIAS PARA EL MEJORAMIENTO DEL AGUA S.A. DE C.V. (951582141)
Registrant - GRUPO TMA TECNOLOGIAS PARA EL MEJORAMIENTO DEL AGUA S.A. DE C.V. (951582141)
Establishment
NameAddressID/FEIBusiness Operations
GRUPO TMA TECNOLOGIAS PARA EL MEJORAMIENTO DEL AGUA S.A. DE C.V.951582141manufacture(80224-1000)

Revised: 2/2021
Document Id: bb6dc692-c164-6b0b-e053-2a95a90ad7f1
Set id: add0e18e-e150-e4e7-e053-2a95a90a5cd8
Version: 4
Effective Time: 20210215
 
GRUPO TMA TECNOLOGIAS PARA EL MEJORAMIENTO DEL AGUA S.A. DE C.V.