BKLEN HANDS SANITIZER- alcohol gel 
Garflo Inc

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.

----------

Bklen Hands Sanitizer

Drug Facts

Active ingredients

Ethyl alcohol 70% 

Purpose

Antiseptic

Uses:

To decrease bacteria on the skin that could cause disease. Recommended for repeated use

Warnings:

For external use only: Hands/ Flammable, keep away from fire or flame.

When using this product:

Keep out of eyes. In case of contact with eyes, flush thoroughly with water/ Avoid contact with broken skin/ Do not inhale or ingest.

Stop use and ask a doctor if

Irritation and redness occurs/ Condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions:

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Other information:

Do not store above 105° F. May discolor some fabrics. Harmful to wood finishes and plastics

Inactive ingredients:

Water, carbomer, aloe, glycerin, isopropyl myristate, tocopheryl acetate

Questions?

Visit www.bklen.com / contact@bklen.com

Package Labeling:59.1ml

Bottle

Package Labeling:236.5ml

Bottle2

Package Labeling:473.1ml

Bottle3

Package Labeling:946.3ml

Bottle4

Package Labeling:3784.6ml

Bottle5

BKLEN HANDS SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81081-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81081-000-0159.1 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
2NDC:81081-000-02236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
3NDC:81081-000-03473.1 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
4NDC:81081-000-04946.3 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
5NDC:81081-000-053784.6 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/09/2020
Labeler - Garflo Inc (061488252)

Revised: 11/2020
Document Id: b462b873-7467-cec3-e053-2995a90aa12f
Set id: b462b873-7466-cec3-e053-2995a90aa12f
Version: 1
Effective Time: 20201118
 
Garflo Inc