BIOPROTECT HAND SANITIZER ISOPROPYL ALCOHOL ANTISEPTIC 75 PERCENT- isopropyl alcohol spray 
Global BioProtect, LLC

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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Bioprotect Hand Sanitizer Isopropyl Alcohol Antiseptic 75%

DRUG FACTS

ACTIVE INGREDIENT(S)

Isopropyl Alcohol 75% v/v

PURPOSE

Antiseptic

USE(S)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

For external use only. 

Flammable.

Keep away from heat or flame.

DO NOT USE:

  • on children less than 2 months of age
  • on open skin wounds

When using this product

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

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

OTHER INFORMATION

Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

DIRECTIONS

Place enough product on hands to cover all surfaces.  Rub hands together until dry.  Supervise children under 6 years of age when using this product to avoid swallowing.

Package Labeling:

Bottle2

BIOPROTECT HAND SANITIZER ISOPROPYL ALCOHOL ANTISEPTIC 75 PERCENT 
isopropyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79141-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79141-002-00236 mL in 1 CAN; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - Global BioProtect, LLC (080387141)
Establishment
NameAddressID/FEIBusiness Operations
Vin Mar Industries LLC114772616manufacture(79141-002) , pack(79141-002)

Revised: 8/2020
Document Id: ad408bb0-8a46-53bb-e053-2995a90a4aec
Set id: 13ceb9b8-3ed7-4916-9257-05051e9496ed
Version: 2
Effective Time: 20200819
 
Global BioProtect, LLC