Hand Sanitizer by BIOJAM, LLC Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by BIOJAM, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- benzalkonium chloride spray 
BIOJAM, 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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Hand Sanitizer

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only

When using this product

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use or ask a doctor if

irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions

Pump a small amount of liquid into palm of hand Rub thoroughly over all surfaces of both hands for 15 seconds Rinse with potable water (Optional).

Inactive Ingredients

Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid.

Package Labeling:

HAND SANITIZER 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76696-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO GLUCOSIDE (UNII: ICS790225B)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76696-000-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020

Labeler - BIOJAM, LLC (117486959)

Revised: 6/2020

Document Id: a7d3ac4a-78bf-b059-e053-2a95a90a4d5e

34390-5

Set id: 804997ff-794c-4c48-9426-ea912d0cc9c2

Version: 1

Effective Time: 20200611