PURE SOLUTIONS ANTISEPTIC WIPES- benzalkonium chloride cloth

Pure Solutions Antiseptic Wipes by

Drug Labeling and Warnings

Pure Solutions Antiseptic Wipes 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

rub wipe 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

glycerin, methylchloroisothiazolinone, methylisothiazonlinone, PEG-40 hydrogenated castor oil, 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

Hand Sanitizing

ANTISEPTIC WIPES

Benzalkonium Chloride 0.1%

Kills Germs

800 Wet Wipes

8 in. x 6 in. (20.3 cm x 15.2 cm)

INGREDIENTS AND APPEARANCE

PURE SOLUTIONS ANTISEPTIC WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77185-004
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 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77185-004-05	800 in 1 POUCH	08/28/2020
1		2.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/28/2020

Labeler - Urban Attitudes Holdings Ltd (117502692)