FDA.reportPublic FDA data

SHIERJIE DISINFECTING SOFT WIPES Antibacterial

Manufacturer
Shenzhen Shierjie Biological Engineering Co., LTD
Effective date
2020-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:31

Label at a glance#

ProductSHIERJIE DISINFECTING SOFT WIPES Antibacterial
Active ingredientBENZALKONIUM CHLORIDE, DIDECYLDIMONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Adults and children 2 years and over Apply to hands Allow to dry without wiping Children under 2 years Ask a doctor before use

Storage and handling

/

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.09%
Dodecyl Dimethyl Ammonium Chloride 0.04 %

Purpose

OTC - PURPOSE SECTION

Antimicrobial

INDICATIONS & USAGE SECTION

Decreases bacteria on skin

Warnings

WARNINGS SECTION

For external use only.Keep away from heat or flame.

OTC - DO NOT USE SECTION

If you are allergic to any of the ingredients.If children less than 2 months of age.

OTC - WHEN USING SECTION

When using this produc, do not get into eyes.If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if iri tation or rash develops and continues for more than 72 hours.

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

Adults and children 2 years and over
Apply to hands
Allow to dry without wiping
Children under 2 years
Ask a doctor before use

Other information

STORAGE AND HANDLING SECTION

/

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Extract , Glycerin , Aqua , Non-woven

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

43116-004-01 1P

43116-004-01 1P43116-004-01 1P

43116-004-02 10P

43116-004-02 10P43116-004-02 10P

43116-004-03 40P

43116-004-03 40P43116-004-03 40P

43116-004-04 50P

43116-004-04 50P43116-004-04 50P

43116-004-05 60P

43116-004-05 60P43116-004-05 60P

43116-004-06 80P

43116-004-06 80P43116-004-06 80P

43116-004-07 90P

43116-004-07 90P43116-004-07 90P

43116-004-08 100P

43116-004-08 100P43116-004-08 100P

43116-004-09 120P

43116-004-09 120P43116-004-09 120P

43116-004-10 60P

43116-004-10 60P43116-004-10 60P

43116-004-11 80P

43116-004-11 80P43116-004-11 80P

43116-004-12 100P

43116-004-12 100P43116-004-12 100P

43116-004-13 120P

43116-004-13 120P43116-004-13 120P

43116-004-14 160P

43116-004-14 160P43116-004-14 160P

43116-004-15 1000P

43116-004-15 1000P43116-004-15 1000P

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43116-026-012022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-022022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-032022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-042022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-052022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-062022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-072022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-082022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-092022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-102022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-112022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-122022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-132022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-142022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial
43116-026-152022-01-28C16284748780-1d6a99b39-9a56-a426-e053-dadaa90af4c243116-026 SHIERJIE DISINFECTING SOFT WIPES Antibacterial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43116-026-01SHIERJIE DISINFECTING SOFT WIPES Antibacterial1 in 1 BAGCLOTH11
43116-026-02SHIERJIE DISINFECTING SOFT WIPES Antibacterial10 in 1 BAGCLOTH101
43116-026-03SHIERJIE DISINFECTING SOFT WIPES Antibacterial40 in 1 BAGCLOTH401
43116-026-04SHIERJIE DISINFECTING SOFT WIPES Antibacterial50 in 1 BAGCLOTH501
43116-026-05SHIERJIE DISINFECTING SOFT WIPES Antibacterial60 in 1 BAGCLOTH601
43116-026-06SHIERJIE DISINFECTING SOFT WIPES Antibacterial80 in 1 BAGCLOTH801
43116-026-07SHIERJIE DISINFECTING SOFT WIPES Antibacterial90 in 1 BAGCLOTH901
43116-026-08SHIERJIE DISINFECTING SOFT WIPES Antibacterial100 in 1 BAGCLOTH1001
43116-026-09SHIERJIE DISINFECTING SOFT WIPES Antibacterial120 in 1 BAGCLOTH1201
43116-026-10SHIERJIE DISINFECTING SOFT WIPES Antibacterial60 in 1 DRUMCLOTH601
43116-026-11SHIERJIE DISINFECTING SOFT WIPES Antibacterial80 in 1 DRUMCLOTH801
43116-026-12SHIERJIE DISINFECTING SOFT WIPES Antibacterial100 in 1 DRUMCLOTH1001
43116-026-13SHIERJIE DISINFECTING SOFT WIPES Antibacterial120 in 1 DRUMCLOTH1201
43116-026-14SHIERJIE DISINFECTING SOFT WIPES Antibacterial160 in 1 DRUMCLOTH1601
43116-026-15SHIERJIE DISINFECTING SOFT WIPES Antibacterial1000 in 1 DRUMCLOTH10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43116-026SHIERJIE DISINFECTING SOFT WIPES ANTIBACTERIAL CLOTH [SHENZHEN SHIERJIE BIOLOGICAL ENGINEERING CO., LTD]1Legacy NDC, 15 package rows20201218_b6a51492-5f14-513e-e053-2995a90a6631.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43116-02643116-026-01, 43116-026-02, 43116-026-03, 43116-026-04, 43116-026-05, 43116-026-06, 43116-026-07, 43116-026-08, 43116-026-09, 43116-026-10, 43116-026-11, 43116-026-12, 43116-026-13, 43116-026-14, 43116-026-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA FLOWER575DY8C1ERIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
b6a505a5-d82f-42b2-e053-2a95a90a9a60b6a51492-5f14-513e-e053-2995a90a66312020-12-17WarningsExact identifier
spl id: b6a505a5-d82f-42b2-e053-2a95a90a9a60
spl set id: b6a51492-5f14-513e-e053-2995a90a6631

Reported adverse events (FAERS/openFDA)#

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