FDA.reportPublic FDA data

antiseptic towelette

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:40:26

Label at a glance#

Productantiseptic towelette 01
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

antiseptic cleansig of face, hands and body to decrease bacteria on skin without soap and water.

Dosage and administration

Tear open packet, unfold and use as a washcloth. Allow hand to dry without wiping.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Fact

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

antiseptic cleansig of face, hands and body to decrease bacteria on skin without soap and water.

Warning

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use in the eyes. If this happens, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develop and 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

Tear open packet, unfold and use as a washcloth. Allow hand to dry without wiping.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Tocopheryl Acetate, Polysorbate 20, Fragrance, Ethylhexylglycerin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82953-004-0782953-004-07

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-004-01antiseptic towelette0110 in 1 BAGCLOTH102
82953-004-02antiseptic towelette0115 in 1 BAGCLOTH152
82953-004-03antiseptic towelette0120 in 1 BAGCLOTH202
82953-004-04antiseptic towelette0130 in 1 BAGCLOTH302
82953-004-05antiseptic towelette0150 in 1 BAGCLOTH502
82953-004-06antiseptic towelette01100 in 1 BAGCLOTH1002
82953-004-07antiseptic towelette011 in 1 BAGCLOTH12
82953-004-08antiseptic towelette0110 in 1 JARCLOTH102
82953-004-09antiseptic towelette0120 in 1 JARCLOTH202
82953-004-10antiseptic towelette0130 in 1 JARCLOTH302
82953-004-11antiseptic towelette0150 in 1 JARCLOTH502
82953-004-12antiseptic towelette0160 in 1 JARCLOTH602
82953-004-13antiseptic towelette01100 in 1 JARCLOTH1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-004ANTISEPTIC TOWELETTE 01 (BENZALKONIUM CHLORIDE) CLOTH [COSMUSES COSMETICS (NINGBO) CO., LTD.]2Current NDC, Legacy NDC, 13 package rows20241206_e9f2a1f1-ceb6-2f20-e053-2a95a90a18db.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
82953-00482953-004-01, 82953-004-02, 82953-004-03, 82953-004-04, 82953-004-05, 82953-004-06, 82953-004-07, 82953-004-08, 82953-004-09, 82953-004-10, 82953-004-11, 82953-004-12, 82953-004-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT

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 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.e9f2a1f1-ceb6-2f20-e053-2a95a90a18db2024-12-04WarningsExact identifier
ndc (package): 82953-004-11
ndc (package): 82953-004-08
ndc (package): 82953-004-07
ndc (package): 82953-004-09
ndc (package): 82953-004-13
ndc (package): 82953-004-03
ndc (package): 82953-004-01
ndc (package): 82953-004-05
ndc (package): 82953-004-12
ndc (package): 82953-004-04
ndc (package): 82953-004-02
ndc (package): 82953-004-10
ndc (package): 82953-004-06
ndc (product): 82953-004
ndc11 (package): 82953000410
ndc11 (package): 82953000411
ndc11 (package): 82953000405
ndc11 (package): 82953000401
ndc11 (package): 82953000407
ndc11 (package): 82953000404
ndc11 (package): 82953000412
ndc11 (package): 82953000406
ndc11 (package): 82953000408
ndc11 (package): 82953000402
ndc11 (package): 82953000413
ndc11 (package): 82953000403
ndc11 (package): 82953000409
spl id: 286c802e-e0fd-9b20-e063-6394a90a504a
spl set id: e9f2a1f1-ceb6-2f20-e053-2a95a90a18db

Reported adverse events (FAERS/openFDA)#

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