PURE SOLUTIONS FOAMING HAND SANITIZING- benzalkonium chloride solution

Pure Solutions Foaming Hand Sanitizing by

Drug Labeling and Warnings

Pure Solutions Foaming Hand Sanitizing by is a Otc medication manufactured, distributed, or labeled by Urban Attitudes Holdings Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzalkonium chloride 0.1%

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

Uses

• to decrease bacteria on the skin
• recommended for repeated use

WARNINGS

Warnings
For external use only.

When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

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

DOSAGE & ADMINISTRATION

Directions

• apply a small amount of product to palm of hand
• rub thoroughly over all sufaces of both hands and allow to dry

STORAGE AND HANDLING

Other information

store between 15-30°C (59-86°F)

INACTIVE INGREDIENT

Inactive ingredients

cocamidopropyl betaine, glycerin, methylchloroisothiazolinone, methylisothiazonlinone, PEG-40 hydrogenated castor oi, tetrasodium EDTA, water

SPL UNCLASSIFIED SECTION

Pure Solutions is a registered trademark of Urban Attitudes Holdings Ltd.

Distributed by: Urban Attititudes Holdings Ltd.

Great Neck, NY 11023 (516) 206-3672

MADE IN PERU

PRINCIPAL DISPLAY PANEL

puresolutions

Foaming Hand Sanitizing Solution

1.057 GALLONS (4 LITERS)

INGREDIENTS AND APPEARANCE

PURE SOLUTIONS FOAMING HAND SANITIZING 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77185-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 0.1 L

Inactive Ingredients
Ingredient Name	Strength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77185-003-04	4 L in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/08/2020

Labeler - Urban Attitudes Holdings Ltd (117502692)