FDA.reportPublic FDA data

DISINFECTING WIPES

Manufacturer
CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.
Effective date
2020-07-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:02

Label at a glance#

ProductDISINFECTING WIPES
Active ingredientDIDECYLDIMONIUM CHLORIDE, BENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Wipe the surface of the skin and let it air dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DISINFECTING WIPES

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.2g/100g
DiDecyl dimethyl ammonium chloride 0.2g/100g

Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, DISINFECTING WIPES

Use

INDICATIONS & USAGE SECTION

DISINFECTING WIPES 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. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

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 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 Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wipe the surface of the skin and let it air dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

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

Phenoxyethanol
Ethylhexyl glycerin
Propylene Glycol
Glycerin
Purified Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75328-301-012022-01-28C16284748780-1d6a99b39-ac1e-a426-e053-dadaa90af4c2DISINFECTING WIPES
75328-301-022022-01-28C16284748780-1d6a99b39-ac1e-a426-e053-dadaa90af4c2DISINFECTING WIPES
75328-301-032022-01-28C16284748780-1d6a99b39-ac1e-a426-e053-dadaa90af4c2DISINFECTING WIPES
75328-301-042022-01-28C16284748780-1d6a99b39-ac1e-a426-e053-dadaa90af4c2DISINFECTING WIPES
75328-301-052022-01-28C16284748780-1d6a99b39-ac1e-a426-e053-dadaa90af4c2DISINFECTING WIPES
75328-301-062022-01-28C16284748780-1d6a99b39-ac1e-a426-e053-dadaa90af4c2DISINFECTING WIPES
75328-301-072022-01-28C16284748780-1d6a99b39-ac1e-a426-e053-dadaa90af4c2DISINFECTING WIPES
75328-301-082022-01-28C16284748780-1d6a99b39-ac1e-a426-e053-dadaa90af4c2DISINFECTING WIPES
75328-301-092022-01-28C16284748780-1d6a99b39-ac1e-a426-e053-dadaa90af4c2DISINFECTING WIPES
75328-301-102022-01-28C16284748780-1d6a99b39-ac1e-a426-e053-dadaa90af4c2DISINFECTING WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75328-301-01DISINFECTING WIPES1 in 1 BAGCLOTH11
75328-301-02DISINFECTING WIPES10 in 1 BAGCLOTH101
75328-301-03DISINFECTING WIPES20 in 1 BAGCLOTH201
75328-301-04DISINFECTING WIPES30 in 1 BAGCLOTH301
75328-301-05DISINFECTING WIPES50 in 1 BAGCLOTH501
75328-301-06DISINFECTING WIPES75 in 1 BAGCLOTH751
75328-301-07DISINFECTING WIPES80 in 1 BAGCLOTH801
75328-301-08DISINFECTING WIPES100 in 1 BAGCLOTH1001
75328-301-09DISINFECTING WIPES120 in 1 BAGCLOTH1201
75328-301-10DISINFECTING WIPES160 in 1 BAGCLOTH1601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75328-301DISINFECTING WIPES (BENZALKONIUM CHLORIDE,DIDECYL DIMETHYL AMMONIUM CHLORIDE) CLOTH [CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.]1Legacy NDC, 10 package rows20200721_aae0c17f-985e-a9bc-e053-2995a90a9bb2.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75328-30175328-301-01, 75328-301-02, 75328-301-03, 75328-301-04, 75328-301-05, 75328-301-06, 75328-301-07, 75328-301-08, 75328-301-09, 75328-301-10

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
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
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
aae0ce1d-c864-58ab-e053-2995a90a865caae0c17f-985e-a9bc-e053-2995a90a9bb22020-07-20WarningsExact identifier
spl id: aae0ce1d-c864-58ab-e053-2995a90a865c
spl set id: aae0c17f-985e-a9bc-e053-2995a90a9bb2

Reported adverse events (FAERS/openFDA)#

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