VITAVIE- benzalkonium chloride solution

VitaVie by

Drug Labeling and Warnings

VitaVie by is a Otc medication manufactured, distributed, or labeled by Spa De Soleil, Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient - Benzalkonium Chloride 0.13%

Purpose - Antispetic Handwash

PURPOSE

Uses - For handwashing to decrease bacteria on the skin

WARNINGS

Warnings - For external use only

WHEN USING

When using this product avoid contact with eyes. In case of eye contact, rinse promptly and thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation and redness occurs for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions: We hands and forearms. Apply a palmful of foam to hands and lather over hands and forearms. Scrub thoroughly. Rinse and dry.

DOSAGE & ADMINISTRATION

Repeat applications as needed.

INACTIVE INGREDIENT

Inactive Ingredients: Aqua, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Chloride, *CO Glycerin, *CO Hamamelis Virginiana (Witch Hazel) Extract, *CO Avena Sativa (Oat) Kernel Extract, *CO Salix Alba (Willow) Bark Extract, *CO Pogostemon Cablin Leaf Extract, *CO Melaleuca Alternifolia (Tea Tree) Leaf Oil, Benzyl Alcohol, Dehydroacetic Acid, Fragrance.

*CO Certified Organic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITAVIE 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-2219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.312 g  in 240 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-2219-1	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/08/2020

Labeler - Spa De Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-2219)