FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.
Effective date
2020-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:35

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place 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.

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

Hand Sanitizer

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 65% v/v. Purpose: Antiseptic

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. 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

  • Place 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water
Propylene Glycol
Glycerin
Isopropyl Myristate
Tocopheryl Acetate
Carbomer
Aminomethyl Propanol
Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75328-101-012022-01-28C16284748780-1d6a99b39-de92-a426-e053-dadaa90af4c2Hand Sanitizer
75328-101-022022-01-28C16284748780-1d6a99b39-de92-a426-e053-dadaa90af4c2Hand Sanitizer
75328-101-032022-01-28C16284748780-1d6a99b39-de92-a426-e053-dadaa90af4c2Hand Sanitizer
75328-101-042022-01-28C16284748780-1d6a99b39-de92-a426-e053-dadaa90af4c2Hand Sanitizer
75328-101-052022-01-28C16284748780-1d6a99b39-de92-a426-e053-dadaa90af4c2Hand Sanitizer
75328-101-062022-01-28C16284748780-1d6a99b39-de92-a426-e053-dadaa90af4c2Hand Sanitizer
75328-101-072022-01-28C16284748780-1d6a99b39-de92-a426-e053-dadaa90af4c2Hand Sanitizer
75328-101-082022-01-28C16284748780-1d6a99b39-de92-a426-e053-dadaa90af4c2Hand Sanitizer
75328-101-092022-01-28C16284748780-1d6a99b39-de92-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75328-101-01Hand Sanitizer30 mL in 1 BOTTLEGEL301
75328-101-02Hand Sanitizer59 mL in 1 BOTTLEGEL591
75328-101-03Hand Sanitizer100 mL in 1 BOTTLEGEL1001
75328-101-04Hand Sanitizer296 mL in 1 BOTTLEGEL2961
75328-101-05Hand Sanitizer473 mL in 1 BOTTLEGEL4731
75328-101-06Hand Sanitizer500 mL in 1 BOTTLEGEL5001
75328-101-07Hand Sanitizer946 mL in 1 BOTTLEGEL9461
75328-101-08Hand Sanitizer1890 mL in 1 BOTTLEGEL18901
75328-101-09Hand Sanitizer3780 mL in 1 BOTTLEGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75328-101HAND SANITIZER (ETHYL ALCOHOL) GEL [CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.]1Legacy NDC, 9 package rows20200716_aa87c169-b3e8-5e0f-e053-2995a90ada9c.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
75328-10175328-101-01, 75328-101-02, 75328-101-03, 75328-101-04, 75328-101-05, 75328-101-06, 75328-101-07, 75328-101-08, 75328-101-09

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
COSTUS ROOT OIL2WF6750061IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
aa87c169-b3e7-5e0f-e053-2995a90ada9caa87c169-b3e8-5e0f-e053-2995a90ada9c2020-07-15WarningsExact identifier
spl id: aa87c169-b3e7-5e0f-e053-2995a90ada9c
spl set id: aa87c169-b3e8-5e0f-e053-2995a90ada9c

Reported adverse events (FAERS/openFDA)#

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