VIVO SIMPLE- isopropyl alcohol spray 
Cuellar Rosas, Juan Alberto

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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VIVO SIMPLE DISINFECTANT SPRAY

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

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)

Revised: 7/2020
Document Id: a97205ef-9740-6aaa-e053-2a95a90a1dc8
Set id: a97205ef-973f-6aaa-e053-2a95a90a1dc8
Version: 1
Effective Time: 20200702
 
Cuellar Rosas, Juan Alberto