Label: VIVO SIMPLE- isopropyl alcohol spray

  • 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 July 2, 2020

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  • DOSAGE AND ADMINSTRATION

    APPLY DIRECTLY TO THE AREA OR SURFACE TO BE DISINFECTED

  • INACTIVE INGREDIENTS

    INACTIVE INGREDIENTS WATER

  • ACTIVE INGREDIENTS

    ALKYL DIMETHYL ETHYLBENZYL AMMONIUM CHLORIDE

    N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE

    ISOPROPYL ALCOHOL

  • INDICATIONS

    APPLY DIRECTLY TO THE AREA OR SURGACE TO BE DISINFECTED. NO DRYING OR RINSING IS NECESSARY. LEAVE IN CONTACT FOR 30 SECONDS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS SECTIONS

    Warnings

    For external use only. Flammable. Keep away from heat or flame

  • WARNINGS AND PRECAUTIONS

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH OCCURS.

  • PURPOSE

    PURPOSE ANTIMICROBIAL

  • PACKAGE LABEL

    Vivo Simple Disinfectant Label

  • INGREDIENTS AND APPEARANCE
    VIVO SIMPLE 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79452-8000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.2 mL  in 1 mL
    N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X) (N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM (C12-C14) - UNII:85440928RV) N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14)0.02 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.78 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79452-8000-13785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
    2NDC:79452-8000-21000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/02/2020
    Labeler - Cuellar Rosas, Juan Alberto (951580031)
    Registrant - Cuellar Rosas, Juan Alberto (951580031)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cuellar Rosas, Juan Alberto951580031manufacture(79452-8000)
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