Nilaqua® ANTISEPTIC HAND SANITIZER

Nilaqua ANTISEPTIC HAND SANITIZER FOAM by

Drug Labeling and Warnings

Nilaqua ANTISEPTIC HAND SANITIZER FOAM by is a Otc medication manufactured, distributed, or labeled by WATERLESS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NILAQUA ANTISEPTIC HAND SANITIZER FOAM- benzalkonium chloride liquid 
WATERLESS LIMITED

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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Nilaqua® ANTISEPTIC HAND SANITIZER

Drug Facts

Active ingredient

Benzalkonium chloride 1.5% w/v 

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

For external use only

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

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

Directions

• wet hands thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

amines, c10-16-alkyldimethyl, n-oxides, didecyl dimethyl ammonium chloride, sodium ethylhexyl sulfate, water

Questions?

+1-855-578-0021

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

Waterless

Kind to Hands

Nilaqua® Sanitiser PLUS

Is an alcohol free, antiseptic hand sanitiser that is kind and gentle to the skin.
Nilaqua leaves hands soft.

alcoholfreesanitiser.co.uk

Fragrance Free

• Fast Drying Formula
• Kind & Gentle to Skin
• Vegan Friendly
• Alcohol & PHMB Free

Approved:
BS EN 1276, 1500, 1650
13623, 13704,
13727, 14348,
12791

Recycle

Manufactured by:

Waterless
Hope Mill, Stroud,
Glos, UK, GL5 2SQ

Made in the UK

Packaging

NILAQUA ANTISEPTIC HAND SANITIZER FOAM 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80349-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
(C10-C16)ALKYLDIMETHYLAMINE OXIDE (UNII: LF6BKC321J)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
SODIUM ETHASULFATE (UNII: 12838560LI)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80349-101-01	55 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/08/2020	11/26/2020
2	NDC: 80349-101-02	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/08/2020	11/26/2020
3	NDC: 80349-101-03	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/08/2020	11/26/2020
4	NDC: 80349-101-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/08/2020	11/26/2020
5	NDC: 80349-101-05	800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/08/2020	11/26/2020
6	NDC: 80349-101-06	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/08/2020	11/26/2020
7	NDC: 80349-101-07	5000 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/08/2020	11/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/08/2020	11/26/2020

Labeler - WATERLESS LIMITED (211503494)

Establishment
Name	Address	ID/FEI	Business Operations
WATERLESS LIMITED		211503494	manufacture(80349-101)

Revised: 11/2020

Document Id: c634e678-7979-4d6d-808a-b7e9b6a2ee68

34390-5

Set id: b2c2f241-29e8-424a-8408-d35d94017c57

Version: 2

Effective Time: 20201126