FDA.reportPublic FDA data

Antiseptic Towelette TOALLITAS ANTISEPTICAS

Manufacturer
M-star (Hubei) Health&Care Products Co., Ltd.
Effective date
2024-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:29

Label at a glance#

ProductAntiseptic Towelette TOALLITAS ANTISEPTICAS
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%.

Purpose:

OTC - PURPOSE SECTION

First Aid Antiseptic

Use:

INDICATIONS & USAGE SECTION

For Professional use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Warning:

WARNINGS SECTION

For external use only.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

Do not use:

OTC - DO NOT USE SECTION

In the eyes, or over large areas of the body.

Directions:

DOSAGE & ADMINISTRATION SECTION

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Purified water.

Question?

OTC - QUESTIONS SECTION

+1(855)924-2182

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label9.jpgLabel9.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84219-004-00Antiseptic Towelette TOALLITAS ANTISEPTICAS1 in 1 POUCHCLOTH11
84219-004-00Antiseptic Towelette TOALLITAS ANTISEPTICAS1 g in 1 PATCHCLOTH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84219-004ANTISEPTIC TOWELETTE TOALLITAS ANTISEPTICAS (BENZALKONIUM CHLORIDE) CLOTH [M-STAR (HUBEI) HEALTH&CARE PRODUCTS CO., LTD.]1Current NDC, 2 package rows20240515_b267e186-cf7a-458f-9c28-a48a8554af40.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84219-00484219-004-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
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
Antiseptic Towelette TOALLITAS ANTISEPTICASBENZALKONIUM CHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.b267e186-cf7a-458f-9c28-a48a8554af402024-04-01WarningsExact identifier
ndc (package): 84219-004-00
ndc (product): 84219-004
ndc11 (package): 84219000400
spl id: 1507887f-14cc-8244-e063-6394a90aeaeb
spl set id: b267e186-cf7a-458f-9c28-a48a8554af40

Reported adverse events (FAERS/openFDA)#

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