HAND SANITIZER- alcohol gel 
BioBarrier360 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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BioBarrier360 Hand Sanitizer

Drug Facts

Active ingredients

Alcohol 70% v/v

Purpose

Antiseptic

Uses

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 thoroughly with water.

Stop use and ask a doctor if

  • Stop use and seek 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.

Directions

Other information

Inactive ingredients

Water, Carbomer, Glycerin, Triethanolamine, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

Questions?

call (877) 458-1315

Company Information

Distributed By:

BioBarrier360 LLC

Austin, TX 78758

www.BioBarrier360.com

Made in Guatemala

Product Packaging - 500 ml

BIOBARRIER360

Hand Sanitizer

with moisturizing ingredients

Alcohol 70%

16.9 fl oz 500 ml

www.BioBarrier360.com

hand sanitizer

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78426-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78426-001-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
2NDC:78426-001-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
3NDC:78426-001-03236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
4NDC:78426-001-04500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
5NDC:78426-001-051000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
6NDC:78426-001-063785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - BioBarrier360 LLC (117535912)

Revised: 6/2020
Document Id: a710ad38-61ee-9321-e053-2995a90a32bc
Set id: a710a11a-b62f-4765-e053-2995a90ac825
Version: 1
Effective Time: 20200601
 
BioBarrier360 LLC