FDA.reportPublic FDA data

Sterilized Wet Wipes

Manufacturer
ZHEJIANG BAOJIA BIOTECHNOLOGY CO., LTD.
Effective date
2020-06-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:27

Label at a glance#

ProductSterilized Wet Wipes
Active ingredientDIDECYLDIMONIUM CHLORIDE, BENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

pull out the wipes to rub all surfaces of hands,. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 5-30℃(41-86F) Avoid freezing and excessive heat above 40(104F)

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%,DDAC 0.1%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Health care personnel hand rub to help reduce bacteria that potentially can cause diseaze.

Warnings

WARNINGS SECTION

For extemal use only, Avoid extreme temperature

Do not use

OTC - DO NOT USE SECTION

In children less than 6 months of age

On open skin wounds

When using this product

OTC - WHEN USING SECTION

Keep out of eyes and mouth, in case of contact with eyes,rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

lf iirritation or rash occurs, these may be signs of a serious condition.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed,get a medical help or call a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

pull out the wipes to rub all surfaces of hands,.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

Store between 5-30℃(41-86F)

Avoid freezing and excessive heat above 40(104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Phenoxyethanol Ethylhexylglycerin, Propylene Glycol,Purfied Water.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6 ml label6 ml label30 ml label30 ml label60 ml label60 ml label90 ml label90 ml label170 ml label170 ml label240 ml label240 ml label300 ml label300 ml label570 ml label570 ml label600 ml label600 ml label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78447-002-012022-01-28C16284748780-1d6a99b39-749f-a426-e053-dadaa90af4c2Sterilized Wet Wipes
78447-002-022022-01-28C16284748780-1d6a99b39-749f-a426-e053-dadaa90af4c2Sterilized Wet Wipes
78447-002-032022-01-28C16284748780-1d6a99b39-749f-a426-e053-dadaa90af4c2Sterilized Wet Wipes
78447-002-042022-01-28C16284748780-1d6a99b39-749f-a426-e053-dadaa90af4c2Sterilized Wet Wipes
78447-002-052022-01-28C16284748780-1d6a99b39-749f-a426-e053-dadaa90af4c2Sterilized Wet Wipes
78447-002-062022-01-28C16284748780-1d6a99b39-749f-a426-e053-dadaa90af4c2Sterilized Wet Wipes
78447-002-072022-01-28C16284748780-1d6a99b39-749f-a426-e053-dadaa90af4c2Sterilized Wet Wipes
78447-002-082022-01-28C16284748780-1d6a99b39-749f-a426-e053-dadaa90af4c2Sterilized Wet Wipes
78447-002-092022-01-28C16284748780-1d6a99b39-749f-a426-e053-dadaa90af4c2Sterilized Wet Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78447-002-01Sterilized Wet Wipes6 mL in 1 BAGCLOTH62
78447-002-02Sterilized Wet Wipes30 mL in 1 BAGCLOTH302
78447-002-03Sterilized Wet Wipes60 mL in 1 BAGCLOTH602
78447-002-04Sterilized Wet Wipes90 mL in 1 BAGCLOTH902
78447-002-05Sterilized Wet Wipes170 mL in 1 BAGCLOTH1702
78447-002-06Sterilized Wet Wipes240 mL in 1 BAGCLOTH2402
78447-002-07Sterilized Wet Wipes300 mL in 1 BAGCLOTH3002
78447-002-08Sterilized Wet Wipes570 mL in 1 BAGCLOTH5702
78447-002-09Sterilized Wet Wipes600 mL in 1 BAGCLOTH6002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78447-002STERILIZED WET WIPES CLOTH [ZHEJIANG BAOJIA BIOTECHNOLOGY CO., LTD.]2Legacy NDC, 9 package rows20200613_a7dc7e1d-c61d-fe4a-e053-2995a90a8b96.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78447-00278447-002-01, 78447-002-02, 78447-002-03, 78447-002-04, 78447-002-05, 78447-002-06, 78447-002-07, 78447-002-08, 78447-002-09

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
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
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
a7dc7e1d-c61e-fe4a-e053-2995a90a8b96a7dc7e1d-c61d-fe4a-e053-2995a90a8b962020-06-12WarningsExact identifier
spl id: a7dc7e1d-c61e-fe4a-e053-2995a90a8b96
spl set id: a7dc7e1d-c61d-fe4a-e053-2995a90a8b96

Reported adverse events (FAERS/openFDA)#

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