ENRICHED FOAM ALCOHOL-FREE HAND SANITIZER- benzalkonium chloride liquid

Enriched Foam by

Drug Labeling and Warnings

Enriched Foam by is a Otc medication manufactured, distributed, or labeled by Rubbermaid Commercial Products LLC, NWL Netherlands Production BV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

0.1% Benzethonium Chloride

Purpose

Antiseptic

Use

To decrease potentially harmful germs on skin.

Warnings

• For external use only.

• When using this product avoid contact with eyes. In case of eye contact, flush with water.

• Stop use and ask a doctor, if irritation or redness persist.

• Do not ingest.

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

Directions

Place hands under the dispenser, allow 0.4 mL of foam into hands, rub thoroughly over the surface of both hands for at least 30 seconds, and then allow hands dry.

Inactive Ingredients

Water (Aqua), Propylene Glycol, PEG-6 Caprylic/Capric Glycerides, Phenoxyethanol, Decylamine Oxide, Tetrasodium Glutamate Diacetate, Sodium Hydroxide, Caprylyl Glycol, Ethylhexylglycerin, Lactic Acid, Disodium Lauriminodipropionate Tocopheryl Phosphates, Benzoic Acid, Dehydroacetic Acid, Shea Butteramidopropyl Betaine, Hexylene Glycol, Sodium Citrate.

Questions?

1-800-347-9800 Mon – Fri, 8 AM – 5 PM EST

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Distributed by Rubbermaid Commercial Products LLC
3124 Valley Avenue, Winchester, VA U.S.A. 22601-2694

PRINCIPAL DISPLAY PANEL - 1100 mL Bag Label

Rubbermaid®
Commercial Products

TECHNICAL CONCEPTS

Enriched Foam Alcohol-Free Hand Sanitizer

1100 mL (37.2 FL. OZ. U.S.)

© 2017 | 2049954 FRONT V-10-2017

INGREDIENTS AND APPEARANCE

ENRICHED FOAM   ALCOHOL-FREE HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65321-033
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
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
PEG-6 Caprylic/Capric Glycerides (UNII: GO50W2HWO8)
Phenoxyethanol (UNII: HIE492ZZ3T)
Decylamine Oxide (UNII: G387VUT5EZ)
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)
Sodium Hydroxide (UNII: 55X04QC32I)
Caprylyl Glycol (UNII: 00YIU5438U)
Ethylhexylglycerin (UNII: 147D247K3P)
Lactic Acid, unspecified form (UNII: 33X04XA5AT)
Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M)
Benzoic Acid (UNII: 8SKN0B0MIM)
Dehydroacetic Acid (UNII: 2KAG279R6R)
Shea Butter (UNII: K49155WL9Y)
Hexylene Glycol (UNII: KEH0A3F75J)
Sodium Citrate, unspecified form (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65321-033-01	6 in 1 BOX	01/01/2018
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 65321-033-02	4 in 1 BOX	01/01/2018
2		1100 mL in 1 BAG; Type 0: Not a Combination Product
3	NDC: 65321-033-03	3 in 1 BOX	01/01/2018
3		1300 mL in 1 BAG; 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	part333A	01/01/2018

Labeler - Rubbermaid Commercial Products LLC (049924368)

Establishment
Name	Address	ID/FEI	Business Operations
NWL Netherlands Production BV		489421698	ANALYSIS(65321-033) , MANUFACTURE(65321-033)