HAND RX ANTIBACTERIAL HAND- benzalkonium chloride liquid
BLUE CROSS LABORATORIES, 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.

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Drug Facts
Active Ingredient

Benzalkonium Chloride 0.13 percent

Purpose

Antibacterial

Uses:

For hand washing 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 (Aqua), Cocamidopropyl Betaine, Sodium Cocoamphoacetate, PEG-150 Distearate, Fragrance, PEG-40 Hydrogenated Castor Oil, Citric Acid, Methylisothiazolinone, Iodopropynyl Butylcarbamate, FD&C Yellow No. 5, FD&C Red No.40, D&C Red No. 33

label

HAND RX ANTIBACTERIAL HAND
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:22431-021
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:22431-021-01	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/01/2020

Labeler - BLUE CROSS LABORATORIES, INC. (008298879)

Registrant - BLUE CROSS LABORATORIES, INC. (008298879)

Drug Facts Active Ingredient