FDA.reportPublic FDA data

Puridene HAND SANITIZER

Manufacturer
Ningbo SKL International Co.,Ltd.
Effective date
2020-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:29

Label at a glance#

ProductPuridene HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

To help reduce bacteria on the skin that could cause disease. For use then soap and water are unavailable.

Dosage and administration

Apply enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To help reduce bacteria on the skin that could cause disease. For use then soap and water are unavailable.

Warnings

WARNINGS SECTION

For external use only
Flammable
Keep away from fire or flame

Do not use:

  • On the children less than 2 months of age
  • On open skin wounds

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, rash occurs. These may be signs of a serious condition

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions 

DOSAGE & ADMINISTRATION SECTION

  • Apply enough product on hands to cover all surfaces.
  • Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

SPL UNCLASSIFIED SECTION

  • Store between 15-30℃(59-86℉).
  • May cause fabric discoloration.
  • May harm plastic and wood finishes.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Aminomethyl propanol, carbomer homopolymer, glycerin, propylene glycol, purified water USP

SPL UNCLASSIFIED SECTION

Questions? 8646160134  Mon. - Fri. 9am-6pm

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74542-015-012022-01-28C16284748780-1d6a99b39-79bf-a426-e053-dadaa90af4c2Puridene
74542-015-022022-01-28C16284748780-1d6a99b39-79bf-a426-e053-dadaa90af4c2Puridene
74542-015-032022-01-28C16284748780-1d6a99b39-79bf-a426-e053-dadaa90af4c2Puridene
74542-015-042022-01-28C16284748780-1d6a99b39-79bf-a426-e053-dadaa90af4c2Puridene
74542-015-052022-01-28C16284748780-1d6a99b39-79bf-a426-e053-dadaa90af4c2Puridene

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74542-015-01Puridene HAND SANITIZER1 mL in 1 BAGGEL11
74542-015-02Puridene HAND SANITIZER2 mL in 1 BAGGEL21
74542-015-03Puridene HAND SANITIZER3 mL in 1 BAGGEL31
74542-015-04Puridene HAND SANITIZER4 mL in 1 BAGGEL41
74542-015-05Puridene HAND SANITIZER5 mL in 1 BAGGEL51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74542-015PURIDENE HAND SANITIZER (ALCOHOL) GEL [NINGBO SKL INTERNATIONAL CO.,LTD.]1Legacy NDC, 5 package rows20200901_e5fc84b4-28fc-443d-8149-229d30dc54bd.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
74542-01574542-015-01, 74542-015-02, 74542-015-03, 74542-015-04, 74542-015-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
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
b7ee805e-9928-4f4c-a065-a8ca837724f1e5fc84b4-28fc-443d-8149-229d30dc54bd2020-08-28WarningsExact identifier
spl id: b7ee805e-9928-4f4c-a065-a8ca837724f1
spl set id: e5fc84b4-28fc-443d-8149-229d30dc54bd

Reported adverse events (FAERS/openFDA)#

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