FOAMING HAND- benzalkonium chloride lotion

Foaming Hand by

Drug Labeling and Warnings

Foaming Hand by is a Otc medication manufactured, distributed, or labeled by OptiSource International, Inc, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

• to decrease bacteria on the skin that could cause disease

Warnings

for external use only: hands

When using this product

• avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• irritation or redness develop
• condition persists for more than 72 hours

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance 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

Inactive ingredients

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, citric acid, tetrasodium EDTA, sodium benzoate

Rear label text

Distributed by:

OptiSource International, Inc

40 Sawgrass Drive, Bellport, NY 11713

principal display panel

Optical

Soap

• Hypoallergenic
• Antibacterial
• Fragrance Free

Sanitizing Foaming Hand Soap

7.5 FL OZ (221 mL)

INGREDIENTS AND APPEARANCE

FOAMING HAND 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75447-224
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)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75447-224-96	222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020

Labeler - OptiSource International, Inc (849200159)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		150931459	manufacture(75447-224)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(75447-224)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(75447-224)