FDA.reportPublic FDA data

AQUATEC SOLUTION ALONGLIFE SANITIZER

Manufacturer
GRUPO TMA TECNOLOGIAS PARA EL MEJORAMIENTO DEL AGUA S.A. DE C.V.
Effective date
2021-02-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:38:09

Key Label Information#

Active Ingredients And Purpose

ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT Active ingredient Chelated Copper Sulfate Pentahydrate .02475 %

PURPOSE

Purpose Antmicrobial, Bactericide, Virucidal

Uses

INDICATION AND USAGE

Use[s] Skin, objects and surface sanitizer to help reduce bacteria and viruses

Warnings

WARNINGS AND PRECAUTIONS

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

WARNINGS

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

DO NOT USE

In children less than 2 months of age.

Directions And Dosage

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.

Other Label Information

INACTIVE INGREDIENTS

Inactive ingredients: Purified demineralized water, Zinc Chelate

PACKAGE LABEL

Label Images#

AQUATEC LABEL 20000 ml
AQUATEC LABEL 20000 ml
AQUATEC LABEL 10000 ml
AQUATEC LABEL 10000 ml
AQUATEC LABE 5000 ml
AQUATEC LABE 5000 ml
AQUATEC LABEL 240ml
AQUATEC LABEL 240ml
AQUATEC LABEL 120ml
AQUATEC LABEL 120ml
Aquatec etiqueta eng FDA 60ml
Aquatec etiqueta eng FDA 60ml
Aquatec Label 490 ml eng FINAL
Aquatec Label 490 ml eng FINAL
Aquatec Label 990 ml eng FINAL
Aquatec Label 990 ml eng FINAL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80224-1000-12023-01-30C16284748780-1f386c64a-2ea3-0266-e053-dadaa90a7c1aAQUATEC SOLUTION ALONGLIFE SANITIZER
80224-1000-22023-01-30C16284748780-1f386c64a-2ea3-0266-e053-dadaa90a7c1aAQUATEC SOLUTION ALONGLIFE SANITIZER
80224-1000-32023-01-30C16284748780-1f386c64a-2ea3-0266-e053-dadaa90a7c1aAQUATEC SOLUTION ALONGLIFE SANITIZER
80224-1000-52023-01-30C16284748780-1f386c64a-2ea3-0266-e053-dadaa90a7c1aAQUATEC SOLUTION ALONGLIFE SANITIZER
80224-1000-62023-01-30C16284748780-1f386c64a-2ea3-0266-e053-dadaa90a7c1aAQUATEC SOLUTION ALONGLIFE SANITIZER
80224-1000-72023-01-30C16284748780-1f386c64a-2ea3-0266-e053-dadaa90a7c1aAQUATEC SOLUTION ALONGLIFE SANITIZER
80224-1000-82023-01-30C16284748780-1f386c64a-2ea3-0266-e053-dadaa90a7c1aAQUATEC SOLUTION ALONGLIFE SANITIZER
80224-1000-92023-01-30C16284748780-1f386c64a-2ea3-0266-e053-dadaa90a7c1aAQUATEC SOLUTION ALONGLIFE SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80224-1000-1AQUATEC ALONGLIFE60 mL in 1 BOTTLESOLUTION604
80224-1000-2AQUATEC ALONGLIFE120 mL in 1 BOTTLESOLUTION1204
80224-1000-3AQUATEC ALONGLIFE240 mL in 1 BOTTLESOLUTION2404
80224-1000-5AQUATEC ALONGLIFE490 mL in 1 BOTTLESOLUTION4904
80224-1000-6AQUATEC ALONGLIFE1000 mL in 1 BOTTLESOLUTION10004
80224-1000-7AQUATEC ALONGLIFE5000 mL in 1 JUGSOLUTION50004
80224-1000-8AQUATEC ALONGLIFE10000 mL in 1 JUGSOLUTION100004
80224-1000-9AQUATEC ALONGLIFE20000 mL in 1 JUGSOLUTION200004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80224-1000AQUATEC ALONGLIFE (CHELATED COPPER SULFATE PENTAHYDRATE) SOLUTION [GRUPO TMA TECNOLOGIAS PARA EL MEJORAMIENTO DEL AGUA S.A. DE C.V.]4Legacy NDC, 8 package rows20210216_add0e18e-e150-e4e7-e053-2a95a90a5cd8.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80224-100080224-1000-5, 80224-1000-6, 80224-1000-7, 80224-1000-8, 80224-1000-9, 80224-1000-1, 80224-1000-2, 80224-1000-3

Ingredients#

Name, UNII, Kind table
NameUNIIKind
CUPRIC SULFATELRX7AJ16DTACTIM
WATER059QF0KO0RIACT
ZINCJ41CSQ7QDSIACT

Complete SPL Sections#

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT Active ingredient Chelated Copper Sulfate Pentahydrate .02475 %

PURPOSE

OTC - PURPOSE SECTION

Purpose Antmicrobial, Bactericide, Virucidal

INDICATION AND USAGE

INDICATIONS & USAGE SECTION

Use[s] Skin, objects and surface sanitizer to help reduce bacteria and viruses

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS

WARNINGS SECTION

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 INGREDIENT SECTION

Inactive ingredients: Purified demineralized water, Zinc Chelate

DO NOT USE

OTC - DO NOT USE SECTION

In children less than 2 months of age.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML