FOAMING HAND- benzalkonium chloride liquid
SHIBY 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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Foaming Hand Soap

Drug Facts

Active Ingredient

0.13% Benalkonium chloride

Purpose

Antibacterial

Use

helps eliminate bacteria on hands

Warning

For external use only

When using this product

do not use in near the eyes. In case of contact, rinse eyes thoroughly with water.

Keep out of reach of children,

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wash hands and rinse

Inactive Ingredients

Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Coconut Oil Diethanolamide, Sodium Lauryl Sulfate, Phenoxyethanol, Parfume, Sodium Benzoate, Citric Acid

Package Labeling:

Bottle

FOAMING HAND
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82110-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82110-001-01	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/27/2021

Labeler - SHIBY INC (855021984)