Label: AQUATEC ALONGLIFE- chelated copper sulfate pentahydrate solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated February 15, 2021

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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