FDA.reportPublic FDA data

Sanitizing Wipes

Manufacturer
Ivy Rose Inc. | Jiangsu Terra Medical Technology Co. Ltd.
Effective date
2020-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:46

Label at a glance#

ProductSanitizing Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure15 sections

Dosage and administration

Adults and children 2 years and over. Apply to hands allow to dry without wiping.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride>=0.1%, Antimicrobial agent

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

if you are allergic to any of the ingredients.

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

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

  • Adults and children 2 years and over.
  • Apply to hands allow to dry without wiping.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water(aqua), Didecyl dimethy ammonium chloride, T5(Glycerin), T3(Aloe), T6(VE), Tributyl phosphate, Citric acid, Alcohol.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 Individually Packed Wipes in 1 BOX NDC: 79247-812-01 Package LabelPackage Label

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 Wipes in 1 BOX NDC: 79247-812-02 Package LabelPackage Label

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 Wipes in 1 BOX NDC: 79247-812-03 Package LabelPackage Label

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80 Wipes in 1 BOX NDC: 79247-812-04 Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN1
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD1
1038856benzalkonium chloride 0.1 % Medicated WipesSY1
1038856benzalkonium chloride 0.1 % Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79247-812-012022-01-28C16284748780-1d6a99b39-939a-a426-e053-dadaa90af4c2aca69b9a-53a9-19fe-e053-2a95a90a69cb
79247-812-022022-01-28C16284748780-1d6a99b39-939a-a426-e053-dadaa90af4c2aca69b9a-53a9-19fe-e053-2a95a90a69cb
79247-812-032022-01-28C16284748780-1d6a99b39-939a-a426-e053-dadaa90af4c2aca69b9a-53a9-19fe-e053-2a95a90a69cb
79247-812-042022-01-28C16284748780-1d6a99b39-939a-a426-e053-dadaa90af4c2aca69b9a-53a9-19fe-e053-2a95a90a69cb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79247-812-01Sanitizing Wipes183 g in 1 BOXCLOTH1831
79247-812-02Sanitizing Wipes122 g in 1 BOXCLOTH1221
79247-812-03Sanitizing Wipes338 g in 1 BOXCLOTH3381
79247-812-04Sanitizing Wipes540 g in 1 BOXCLOTH5401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79247-812SANITIZING WIPES (HAND SANITIZER) CLOTH [IVY ROSE INC.]1Legacy NDC, 4 package rows20200815_aca69b9a-53a9-19fe-e053-2a95a90a69cb.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
79247-81279247-812-01, 79247-812-02, 79247-812-03, 79247-812-04

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
GLYCERINPDC6A3C0OXIACT
ALOEV5VD430YW9IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALCOHOL3K9958V90MIACT
TOCOPHEROLR0ZB2556P8IACT
TRI-N-BUTYL PHOSPHATE95UAS8YAF5IACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
aca69548-34ac-41c9-e053-2995a90a8153aca69b9a-53a9-19fe-e053-2a95a90a69cb2020-08-12WarningsExact identifier
spl id: aca69548-34ac-41c9-e053-2995a90a8153
spl set id: aca69b9a-53a9-19fe-e053-2a95a90a69cb

Reported adverse events (FAERS/openFDA)#

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