BIOPROTECT ALCOHOL FREE HAND SANITIZER- benzalkonium chloride 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 Alcohol Free Hand Sanitizer

DRUG FACTS

Active Ingredient:

Benzalkonium Chloride 0.13%

Purpose:

Antiseptic Hand Sanitizer

Uses:

Hand Sanitizer to help decrease bacteria on the skin - Recommended for repeated use.

Warnings:

Do not freeze.
For external use only.
Do not use in ears or mouth.

When using this product,

  • avoid contact with the eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor

  • if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

  • Children should be supervised when using this product.

Directions:

Apply a small amount into palms and spread on both hands. Rub into skin until dry

Inactive Ingredients:

Water, Polyaminopropyl biguanide, 1-Octadecanaminum NN dimethyl(3-trimethoxysilyl) propyl chloride, C12-15 Pareth 12, Caprylyl Glucoside, Benzalkonium Chloride 50%, Sodium Benzoate, Glycerin, Aloe Barbadensis Leaf Juice Extract, Citronellol, Citric Acid, FD&C Blue No. 1

Package Labeling:

Bottle

BIOPROTECT ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79141-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
C12-15 PARETH-12 (UNII: 131316X18L)  
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79141-001-00236 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 LLC114772616pack(79141-001)
Establishment
NameAddressID/FEIBusiness Operations
BRENNTAG MID-SOUTH, INC.122625064manufacture(79141-001)

Revised: 8/2020
Document Id: ad408fc9-a90e-102f-e053-2995a90a4d0f
Set id: 8f6bd74f-307b-4a27-93a1-76ed01668164
Version: 2
Effective Time: 20200819
 
Global BioProtect, LLC