FDA.reportPublic FDA data

Alcosm Antibacterial wipes

Manufacturer
Kangna (Zhejiang) Medical Supplies Co., Ltd.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:58

Label at a glance#

ProductAlcosm Antibacterial wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Dosage and administration

Remove lid. Pull wipe from center of roll and thread through opening in lid. Do not push finger through opening. Replace lid, pull wipe up and then out at 45° angle. Next wipe dispenses automatically. Close lid to retain moisture.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.3%

Purpose

OTC - PURPOSE SECTION

Antiseptic

USE

INDICATIONS & USAGE SECTION

●For hand sanitizing to decrease bacteria on the skin.
●Apply topically to the skin to help prevent cross contamination.
●Not recommended for repeated use.
●Dries in seconds.

Warning

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame.
When using this product keep out of eyes, ears, and mouth. In case of eye contact, flush thoroughly with water.
Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Remove lid. Pull wipe from center of roll and thread through opening in lid. Do not push finger through
opening. Replace lid, pull wipe up and then out at 45° angle. Next wipe dispenses automatically. Close lid to retain moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Phenoxyethanol, DMDM Hydantoin, Ethylparaben, Methylparaben, Polysorbate 20, Fragrance, Disodium
EDTA, Sodium Citrate, Cetylpyridinium Chloride.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1812737benzalkonium Cl 0.3 % Medicated PadPSN2
1812737benzalkonium chloride 3 MG/ML Medicated PadSCD2
1812737benzalkonium chloride 0.3 % Medicated WipeSY2
1812737benzalkonium chloride 0.3 % Topical ClothSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75109-507-012024-01-30C16284748780-11030e365-0754-111a-e063-dadaa90a10e275109-507 Alcosm Antibacterial Wipes 0.3% Benzalkonium Chloride
75109-507-022024-01-30C16284748780-11030e365-0754-111a-e063-dadaa90a10e275109-507 Alcosm Antibacterial Wipes 0.3% Benzalkonium Chloride
75109-507-032024-01-30C16284748780-11030e365-0754-111a-e063-dadaa90a10e275109-507 Alcosm Antibacterial Wipes 0.3% Benzalkonium Chloride
75109-507-042024-01-30C16284748780-11030e365-0754-111a-e063-dadaa90a10e275109-507 Alcosm Antibacterial Wipes 0.3% Benzalkonium Chloride
75109-507-052024-01-30C16284748780-11030e365-0754-111a-e063-dadaa90a10e275109-507 Alcosm Antibacterial Wipes 0.3% Benzalkonium Chloride
75109-507-062024-01-30C16284748780-11030e365-0754-111a-e063-dadaa90a10e275109-507 Alcosm Antibacterial Wipes 0.3% Benzalkonium Chloride
75109-507-072024-01-30C16284748780-11030e365-0754-111a-e063-dadaa90a10e275109-507 Alcosm Antibacterial Wipes 0.3% Benzalkonium Chloride
75109-507-082024-01-30C16284748780-11030e365-0754-111a-e063-dadaa90a10e275109-507 Alcosm Antibacterial Wipes 0.3% Benzalkonium Chloride
75109-507-092024-01-30C16284748780-11030e365-0754-111a-e063-dadaa90a10e275109-507 Alcosm Antibacterial Wipes 0.3% Benzalkonium Chloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75109-507-01Alcosm Antibacterial wipes1 in 1 PACKAGECLOTH12
75109-507-01Alcosm Antibacterial wipes600 in 1 CARTONCLOTH6002
75109-507-02Alcosm Antibacterial wipes100 in 1 CARTONCLOTH1002
75109-507-02Alcosm Antibacterial wipes10 in 1 PACKAGECLOTH102
75109-507-03Alcosm Antibacterial wipes24 in 1 CARTONCLOTH242
75109-507-03Alcosm Antibacterial wipes50 in 1 PACKAGECLOTH502
75109-507-04Alcosm Antibacterial wipes80 in 1 PACKAGECLOTH802
75109-507-04Alcosm Antibacterial wipes16 in 1 CARTONCLOTH162
75109-507-05Alcosm Antibacterial wipes16 in 1 CARTONCLOTH162
75109-507-05Alcosm Antibacterial wipes100 in 1 PACKAGECLOTH1002
75109-507-06Alcosm Antibacterial wipes75 in 1 CANISTERCLOTH752
75109-507-06Alcosm Antibacterial wipes12 in 1 CARTONCLOTH122
75109-507-07Alcosm Antibacterial wipes12 in 1 CARTONCLOTH122
75109-507-07Alcosm Antibacterial wipes150 in 1 CANISTERCLOTH1502
75109-507-08Alcosm Antibacterial wipes12 in 1 CARTONCLOTH122
75109-507-08Alcosm Antibacterial wipes240 in 1 CANISTERCLOTH2402
75109-507-09Alcosm Antibacterial wipes350 in 1 CANISTERCLOTH3502
75109-507-09Alcosm Antibacterial wipes2 in 1 CARTONCLOTH22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75109-507ALCOSM ANTIBACTERIAL WIPES (BENZALKONIUM CHLORIDE) CLOTH [KANGNA (ZHEJIANG) MEDICAL SUPPLIES CO., LTD.]2Legacy NDC, 18 package rows20220115_a9bc0a27-d4e5-7a9d-e053-2995a90a21b0.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75109-50775109-507-01, 75109-507-02, 75109-507-03, 75109-507-04, 75109-507-05, 75109-507-06, 75109-507-07, 75109-507-08, 75109-507-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
WATER059QF0KO0RIACT
DMDM HYDANTOINBYR0546TOWIACT
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLPARABEN14255EXE39IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM CITRATE1Q73Q2JULRIACT

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
d5871722-d027-3632-e053-2995a90a4cc0a9bc0a27-d4e5-7a9d-e053-2995a90a21b02022-01-14WarningsExact identifier
spl id: d5871722-d027-3632-e053-2995a90a4cc0
spl set id: a9bc0a27-d4e5-7a9d-e053-2995a90a21b0

Reported adverse events (FAERS/openFDA)#

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