SANITIZING HAND- benzalkonium chloride soap

Sanitizing Hand by

Drug Labeling and Warnings

Sanitizing Hand by is a Otc medication manufactured, distributed, or labeled by BELLA BRANDS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• Kills 99.9% of Germs
• Safe for Sensitive Skin
• Foaming Hand Wash

Paraben Free
No Artificial Fragrance
Made with Organic Ingredients

12.5 fl oz (370 ml)

INGREDIENTS AND APPEARANCE

SANITIZING HAND 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80994-004
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80994-004-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
2	NDC: 80994-004-02	370 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Not Final	part333A	05/01/2020

Labeler - BELLA BRANDS INC (034908755)

Establishment
Name	Address	ID/FEI	Business Operations
BELLA BRANDS INC		034908755	MANUFACTURE(80994-004)