Antibacterial Handsoap by BLUE CROSS LABORATORIES Antibacterial Handsoap

Antibacterial Handsoap by

Drug Labeling and Warnings

Antibacterial Handsoap by is a Otc medication manufactured, distributed, or labeled by BLUE CROSS LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL HANDSOAP- benzalkonium chloride gel 
BLUE CROSS LABORATORIES

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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Antibacterial Handsoap

Active Ingredient(s)

Benzalkonium Chloride 0.13%. Purpose: Antibacterial

Purpose

Antibacterial, Hand soap

Uses

For handwashing to decrease bacteria on the skin

Warnings

For external use only

When using this product

• Avoid contact with eyes. In case of eye contact, flush with water

Stop use and ask a doctor

if irritation and redness develops.

Keep out of reach of children.

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

Directions

• wet hands as needed
• Lather vigorously for at least 15 seconds
• Wash skin, rinse and dry thoroughly

Inactive ingredients

Water, Sodlium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide DIPA, Glycerin, Citric acid, Methylisothiazolinone, Fragrance, Sodium Chloride, FD&C Red 40, D&C Red 33, FD&C Yellow 5

Package Label - Principal Display Panel

355 mL NDC: 22431-152-01

ANTIBACTERIAL HANDSOAP 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22431-152(NDC: 75729-004)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22431-152-01	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2020	08/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/06/2020	08/06/2020

Labeler - BLUE CROSS LABORATORIES (008298879)

Revised: 6/2021

Document Id: c439c202-17d3-45f8-e053-2995a90a284d

34390-5

Set id: ac3dded2-79f7-628a-e053-2a95a90af18c

Version: 2

Effective Time: 20210607