VITAVIE- benzalkonium chloride solution 
Spa De Soleil

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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Vita Vie

Active Ingredient - Benzalkonium Chloride 0.13%

Purpose - Antispetic Handwash

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, rinse promptly and thoroughly with water.

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

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

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

Repeat applications as needed.

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

VV Hand Soap.jpg

VITAVIE 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-2219
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.312 g  in 240 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68062-2219-1240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/08/2020
2NDC:68062-2219-21893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/08/2020
Labeler - Spa De Soleil (874682867)
Establishment
NameAddressID/FEIBusiness Operations
Spa de Soleil874682867manufacture(68062-2219)

Revised: 6/2023
Document Id: fd69cceb-aec1-ee89-e053-6294a90affa6
Set id: a2d20b90-bd16-027d-e053-2a95a90a4719
Version: 2
Effective Time: 20230605
 
Spa De Soleil