FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Zhejiang Yiwu Limei Cosmetics Co., Ltd
Effective date
2020-05-30
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-05-31 23:15:25

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

wet hands thoroughly with product. Briskly rub hands together until dry. supervise children under 6 years in the use of this product

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

NA

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin. Recommended for repeated use.

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 and redness develop and persist for more than 72 hours.

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

  • wet hands thoroughly with product.
  • Briskly rub hands together until dry.
  • supervise children under 6 years in the use of this product

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

purified water, propylene glycol , glycerin, carbomer, triethanolamine, aloe barbadensis leaf juice, citric acid, potassium sorbate, sodium benzoate.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 74765-013-01 60ML LABEL60ML LABEL

300 mL NDC: 74765-013-02

500 mL NDC: 74765-013-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN14
1305100ethanol 0.75 ML/ML Topical GelSCD14
1305100ethanol 75 % Topical GelSY14

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74765-013-012022-01-28C16284748780-1d6a99b39-c198-a426-e053-dadaa90af4c2a522e8e5-a6af-d314-e053-2a95a90a32c7
74765-013-022022-01-28C16284748780-1d6a99b39-c198-a426-e053-dadaa90af4c2a522e8e5-a6af-d314-e053-2a95a90a32c7
74765-013-032022-01-28C16284748780-1d6a99b39-c198-a426-e053-dadaa90af4c2a522e8e5-a6af-d314-e053-2a95a90a32c7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74765-013-01Hand Sanitizer60 mL in 1 BOTTLEGEL6014
74765-013-02Hand Sanitizer300 mL in 1 BOTTLEGEL30014
74765-013-03Hand Sanitizer500 mL in 1 BOTTLEGEL50014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74765-013HAND SANITIZER (ALCOHOL) GEL [ZHEJIANG YIWU LIMEI COSMETICS CO., LTD]14Legacy NDC, 3 package rows20200531_a522e8e5-a6af-d314-e053-2a95a90a32c7.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
74765-01374765-013-01, 74765-013-02, 74765-013-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9804Q93RCW27EIACT
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML · Source PDF

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
a6e788c4-bd04-177a-e053-2a95a90afb65a522e8e5-a6af-d314-e053-2a95a90a32c72020-05-30WarningsExact identifier
spl id: a6e788c4-bd04-177a-e053-2a95a90afb65
spl set id: a522e8e5-a6af-d314-e053-2a95a90a32c7

Reported adverse events (FAERS/openFDA)#

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