SANITIZING HAND- benzalkonium chloride soap 
BELLA BRANDS 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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Sanitizing Hand

Drug Facts:

Active Ingredient

Benzalkonium Chloride, 0.13%

Purpose

Antimicrobial Agent

Use

for cleansing hands and decreasing bacteria on the skin.

Warnings

- For external use only.

- Do not use if you are allergic to any of the ingredients.

- When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water.

- Stop use and consult a doctor if irritation or rash develops and continues for more than 72 hours.

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

Inactive Ingredients

Water, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Polysorbate 20, Sucrose Cocoate, Glycerin, Polyquaternium-7, Hydroxyethylcellulose, Phenoxyethanol, Ethylhexylglycerin, Tetrasodium EDTA, Fragrance (Naturally Derived), Aloe Vera Barbadensis Leaf Juice1, Chamomilla Recutita (Matricaria) Flower Extract1, Camelia Sinensis Leaf Extract1, Vitis Vinifera (Grapeseed) Extract1, Helianthus Annuus (Sunflower) Seed Oil1


1
Organic Ingredient

Directions For Use

- Press dispensing pump to release product into hands, add water and rub thoroughly around both sides of hands and between fingers. Rinse off and towel dry.

- For adults and children 2 years and over.

- For children under 2 years of age, consult a doctor before use.

PRINCIPAL DISPLAY PANEL - 370 ml Bottle Label

PURIGEN™

Sanitizing
Hand Soap

Paraben Free
No Artificial Fragrance
Made with Organic Ingredients

12.5 fl oz (370 ml)

PRINCIPAL DISPLAY PANEL - 370 ml Bottle Label
SANITIZING HAND 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80994-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Cocamidopropylamine Oxide (UNII: M4SL82J7HK)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Sucrose Cocoate (UNII: 3H18P0UK73)  
Glycerin (UNII: PDC6A3C0OX)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Edetate Sodium (UNII: MP1J8420LU)  
Chamomile (UNII: FGL3685T2X)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Vitis Vinifera Seed (UNII: C34U15ICXA)  
Sunflower Oil (UNII: 3W1JG795YI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80994-004-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
2NDC:80994-004-02370 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Not Finalpart333A05/01/2020
Labeler - BELLA BRANDS INC (034908755)
Establishment
NameAddressID/FEIBusiness Operations
BELLA BRANDS INC034908755MANUFACTURE(80994-004)

Revised: 11/2020
Document Id: f776b4e6-3dce-4eda-af29-d037552fd5e8
Set id: 8d61ad48-6df6-4853-b4f8-91f335bc6832
Version: 1
Effective Time: 20201118
 
BELLA BRANDS INC