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 0.8% w/v

Purpose

Antiseptic

Uses

Warnings

For external use only

Do not use

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

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

Directions

Other information

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

Kind to Hands

Nilaqua®Antiseptic Hand Sanitizer

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

Approved:
BS EN 1276, 1500, 1650
13623, 13704, 13727, 14348,
12791, 14476 2013 +A2:2019

alcoholfreesanitiser.com.√

Recycle

Manufactured by: Waterless
Hope Mill, Stroud,
Glos, UK, GL5 2SQ

Made in the UK

Packaging

untitled

NILAQUA ANTISEPTIC HAND SANITIZER FOAM 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80349-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
(C10-C16)ALKYLDIMETHYLAMINE OXIDE (UNII: LF6BKC321J)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
SODIUM ETHASULFATE (UNII: 12838560LI)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80349-102-0155 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/08/2020
2NDC:80349-102-02100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/08/2020
3NDC:80349-102-03200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/08/2020
4NDC:80349-102-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/08/2020
5NDC:80349-102-05800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/08/2020
6NDC:80349-102-061000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/08/2020
7NDC:80349-102-075000 mL in 1 CONTAINER; Type 0: Not a Combination Product01/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/08/2020
Labeler - WATERLESS LIMITED (211503494)
Establishment
NameAddressID/FEIBusiness Operations
WATERLESS LIMITED211503494manufacture(80349-102)

Revised: 11/2020
Document Id: f75a7992-f1ae-404d-88bd-bd35213e7644
Set id: cd451804-1532-46bb-868e-641b4561b1db
Version: 1
Effective Time: 20201107
 
WATERLESS LIMITED