FDA.reportPublic FDA data

BATHEAL HAND SANITIZING WIPES

Manufacturer
SUNJU CORPORATION | SHINE CO.,LTD
Effective date
2020-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:27:33

Label at a glance#

ProductBATHEAL HAND SANITIZING WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

For adults and children of 3 years and over, wet hands thoroughly with product and allow to dry. Supervise children under 6 years of age when using this product.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use(s)

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

For External use only. For children under 3 years of age, consult with a doctor before use.

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body
  • if you are allergic to any of the ingredients

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash develops and continues 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

  • For adults and children of 3 years and over, wet hands thoroughly with product and allow to dry.
  • Supervise children under 6 years of age when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol, Sodium Hydroxide, Fragnance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 75272-004-10NDC 75272-004-10

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75272-004-102025-12-23C16284748780-1d6a99b39-f4ad-a426-e053-dadaa90af4c2a790b3ce-eaad-28ba-e053-2995a90aeb99
75272-004-102022-01-28C16284748780-1d6a99b39-f4ad-a426-e053-dadaa90af4c2a790b3ce-eaad-28ba-e053-2995a90aeb99

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75272-004BATHEAL HAND SANITIZING WIPES (HAND SANITIZING WIPES) CLOTH [SUNJU CORPORATION]1Legacy NDC20200609_a790b3ce-eaad-28ba-e053-2995a90aeb99.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75272-00475272-004-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
SODIUM HYDROXIDE55X04QC32IIACT
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
46984b78-78d6-7712-e063-6294a90a3d44a790b3ce-eaad-28ba-e053-2995a90aeb992025-12-22WarningsExact identifier
spl set id: a790b3ce-eaad-28ba-e053-2995a90aeb99

Reported adverse events (FAERS/openFDA)#

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