FDA.reportPublic FDA data

Nilaqua ANTISEPTIC HAND SANITIZER FOAM

Manufacturer
WATERLESS LIMITED
Effective date
2020-11-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:48

Label at a glance#

ProductNilaqua ANTISEPTIC HAND SANITIZER FOAM
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.8% w/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions? +1-855-578-0021

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Kind to Hands

Nilaqua®Antiseptic Hand Sanitizer

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

  • 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, 14476 2013 +A2:2019

alcoholfreesanitiser.com.√

Recycle

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

Made in the UK

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2464108benzalkonium chloride 0.8 % Topical FoamPSN1
2464108benzalkonium chloride 8 MG/ML Topical FoamSCD1
2464108benzalkonium chloride 0.8 % Topical FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80349-102-012022-01-28C16284748780-1d6a99b39-e5fb-a426-e053-dadaa90af4c2Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-022022-01-28C16284748780-1d6a99b39-e5fb-a426-e053-dadaa90af4c2Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-032022-01-28C16284748780-1d6a99b39-e5fb-a426-e053-dadaa90af4c2Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-042022-01-28C16284748780-1d6a99b39-e5fb-a426-e053-dadaa90af4c2Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-052022-01-28C16284748780-1d6a99b39-e5fb-a426-e053-dadaa90af4c2Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-062022-01-28C16284748780-1d6a99b39-e5fb-a426-e053-dadaa90af4c2Nilaqua ® ANTISEPTIC HAND SANITIZER
80349-102-072022-01-28C16284748780-1d6a99b39-e5fb-a426-e053-dadaa90af4c2Nilaqua ® ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80349-102-01Nilaqua ANTISEPTIC HAND SANITIZER FOAM55 mL in 1 BOTTLE, PUMPLIQUID551
80349-102-02Nilaqua ANTISEPTIC HAND SANITIZER FOAM100 mL in 1 BOTTLE, SPRAYLIQUID1001
80349-102-03Nilaqua ANTISEPTIC HAND SANITIZER FOAM200 mL in 1 BOTTLE, PUMPLIQUID2001
80349-102-04Nilaqua ANTISEPTIC HAND SANITIZER FOAM500 mL in 1 BOTTLE, PUMPLIQUID5001
80349-102-05Nilaqua ANTISEPTIC HAND SANITIZER FOAM800 mL in 1 BOTTLE, PUMPLIQUID8001
80349-102-06Nilaqua ANTISEPTIC HAND SANITIZER FOAM1000 mL in 1 BOTTLE, PUMPLIQUID10001
80349-102-07Nilaqua ANTISEPTIC HAND SANITIZER FOAM5000 mL in 1 CONTAINERLIQUID50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80349-102NILAQUA ANTISEPTIC HAND SANITIZER FOAM (BENZALKONIUM CHLORIDE) LIQUID [WATERLESS LIMITED]1Legacy NDC, 7 package rows20201117_cd451804-1532-46bb-868e-641b4561b1db.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80349-10280349-102-01, 80349-102-02, 80349-102-03, 80349-102-04, 80349-102-05, 80349-102-06, 80349-102-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
(C10-C16)ALKYLDIMETHYLAMINE OXIDELF6BKC321JIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
SODIUM ETHASULFATE12838560LIIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f75a7992-f1ae-404d-88bd-bd35213e7644cd451804-1532-46bb-868e-641b4561b1db2020-11-07WarningsExact identifier
spl id: f75a7992-f1ae-404d-88bd-bd35213e7644
spl set id: cd451804-1532-46bb-868e-641b4561b1db

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.