FDA.reportPublic FDA data

NATRULAB ANTISEPTIC SANITIZING WIPES

Manufacturer
Natrulab Innovations Inc
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:10

Label at a glance#

ProductNATRULAB ANTISEPTIC SANITIZING WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Storage and handling

OTHER INFORMATION Do not store above 104℉ (40℃) Do not use if the seal is damaged or broken

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

Benzalkonium Chloride - 0.26% (w/w)

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

USE

For hand washing to decrease bacteria on skin.

Recommended for repeated use.

WARNINGS SECTION

WARNINGS

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

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.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

Apply to clean dry hands. Wet hands thoroughly with the product and allow to dry. Children under 6 should be supervised when using this product.

STORAGE AND HANDLING SECTION

OTHER INFORMATION

Do not store above 104℉ (40℃)

Do not use if the seal is damaged or broken

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Water, Sodium Hydroxymethylglycinate, Citric Acid, Aloe Barbadensis Leaf Water, Sodium Chloride, Sodium Benzoate, Potassium Sorbate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 COUNT REFILL BAG

NDC: 83086-001-01

1000 COUNT Label1000 COUNT Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2619739benzalkonium chloride 0.26 % Medicated PadPSN4
2619739benzalkonium chloride 2.6 MG/ML Medicated PadSCD4
2619739benzalkonium chloride 0.26 % Medicated PadSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83086-001-012025-01-30C16284748780-12cef2736-a906-d83d-e063-dadaa90ab31f83086-001 NATRULAB ANTISEPTIC SANITIZING WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83086-001-01NATRULAB ANTISEPTIC SANITIZING WIPES1000 in 1 BAGCLOTH10004
83086-001-01NATRULAB ANTISEPTIC SANITIZING WIPES0.012 g in 1 APPLICATORCLOTH0.0124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83086-001NATRULAB ANTISEPTIC SANITIZING WIPES (ANTISEPTIC SANITIZING WIPES) CLOTH [NATRULAB INNOVATIONS INC]4Legacy NDC, 2 package rows20231106_ec8829a0-280b-08ef-e053-2a95a90af75c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83086-00183086-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SODIUM HYDROXYMETHYLGLYCINATEDIG6BWZ9XTIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
09735b2f-2b02-ca91-e063-6294a90a210aec8829a0-280b-08ef-e053-2a95a90af75c2023-11-05WarningsExact identifier
spl id: 09735b2f-2b02-ca91-e063-6294a90a210a
spl set id: ec8829a0-280b-08ef-e053-2a95a90af75c

Reported adverse events (FAERS/openFDA)#

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