FDA.reportPublic FDA data

Comix Hand Sanitizing Wipes

Manufacturer
Shantou Shengmei Biotechnology Co., Ltd.
Effective date
2020-08-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:24

Label at a glance#

ProductComix Hand Sanitizing Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

For hand washing to decrease bacteria on the skin. Recommended for repeat use.

Dosage and administration

Apply to skin as needed. Discard after single use. Always snap lid securely shut between uses to prevent moisture loss. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, wipes

Uses

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin. Recommended for repeat use.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on children less than 6 months of age, and on open skin wounds.

When using this product

OTC - WHEN USING SECTION

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask doctor

OTC - STOP USE SECTION

if irritation or rash occurs, persists for more than 72 hours.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to skin as needed. Discard after single use. Always snap lid securely shut between uses to prevent moisture loss. Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

OTHER SAFETY INFORMATION

Protect from freezing and avoid excessive heat. Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F). * This product can effectively kills 99.99% Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa under experimental conditions. The results are for reference only.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Decyl D-glucoside, 2-Phenoxyethanol, Methyl 4-hydroxybenzoate, Propyl 4-hydroxybenzoate, Parfum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55450-008-01 50PCS

Comix

Kills 99.99% of Germs*

HAND SANITIZING WIPES

Alcohol-free

Gentel Sterilization

Soft and skin friendly

Moisture and clean

Healthy, alcohol-free

L909

50 PCS

Wipe Dimensions

20cm X 15cm (7.9in X 5.9in)

Skin Health

For skin ad hands disinfection

PDPPDP

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55450-008-012022-01-28C16284748780-1d6a99b39-dff4-a426-e053-dadaa90af4c2Comix Hand Sanitizing Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55450-008-01Comix Hand Sanitizing Wipes50 in 1 BAGCLOTH501
55450-008-01Comix Hand Sanitizing Wipes5.8 g in 1 PATCHCLOTH5.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55450-008COMIX HAND SANITIZING WIPES (BENZALKONIUM CHLORIDE) CLOTH [SHANTOU SHENGMEI BIOTECHNOLOGY CO., LTD.]1Legacy NDC, 2 package rows20200821_ad566d17-e235-332c-e053-2995a90a1df2.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55450-00855450-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERINPDC6A3C0OXIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT

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
ad566300-956d-213a-e053-2a95a90a9d49ad566d17-e235-332c-e053-2995a90a1df22020-08-20WarningsExact identifier
spl id: ad566300-956d-213a-e053-2a95a90a9d49
spl set id: ad566d17-e235-332c-e053-2995a90a1df2

Reported adverse events (FAERS/openFDA)#

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