FDA.reportPublic FDA data

ECOLAB Antiseptic

Manufacturer
Ecolab Food Safety Specialties, Inc. | Medique Products | Changzhou Maokang Medical Products Co., Ltd
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:35:21

Label at a glance#

ProductECOLAB Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium Chloride, 0.13%

OTC - PURPOSE SECTION

Purpose

First aid antiseptic

INDICATIONS & USAGE SECTION

Uses

First aid to help reduce the risk of infection in minor cuts, scrapes and burns.

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • in the eyes or over large areas of the body
  • in case of deep puncture wounds, animal bites or serious burns, consult a doctor
  • longer than 1 week unless directed by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • the condition persists or gets worse

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

  • tear open packet, unfold and clean the affected area
  • discard after use

OTHER SAFETY INFORMATION

Other information

  • store at room temperature 59°-86°F (15°-30°C)
  • tamper evident sealed packets
  • do not use any open or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

sodium bicarbonate, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-321-3687

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANSI/ISEA Required

Ecolab®

Antiseptic Wipes

Reorder # 22

Benzalkonium chloride 0.13%

First Aid Antiseptic

20 extra large wipes per box

Tamper Evident Sealed Packets

Ecolab Antiseptic Wipes 91471 Dukal 7-25-24Ecolab Antiseptic Wipes 91471 Dukal 7-25-24

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71338-312-71ECOLAB Antiseptic1.4 mL in 1 PACKETLIQUID1.42
71338-312-71ECOLAB Antiseptic20 in 1 BOXLIQUID202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71338-312ECOLAB ANTISEPTIC (BENZALKONIUM CHLORIDE) LIQUID [ECOLAB FOOD SAFETY SPECIALTIES, INC.]22 package rows20241109_246e53bc-7a65-876c-e063-6294a90aab6d.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71338-31271338-312-71

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
2652f664-5f59-a0e3-e063-6394a90a00d3246e53bc-7a65-876c-e063-6294a90aab6d2024-11-07WarningsExact identifier
spl id: 2652f664-5f59-a0e3-e063-6394a90a00d3
spl set id: 246e53bc-7a65-876c-e063-6294a90aab6d

Reported adverse events (FAERS/openFDA)#

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