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
16
Source
full-release
Hydrated at
2026-05-31 23:15:29

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 and redness develop and persist for more than 72 hours.

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, Aloe Barbadensis Leaf Juice, Citric Acid, Potassium Sorbate, Sodium Benzoate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 74765-016-01

180 mL NDC: 74765-016-02 180ml label180ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286295ethanol 75 % Topical SprayPSN16
2286295ethanol 0.75 ML/ML Topical SpraySCD16
2286295ethanol 75 % Topical SpraySY16

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74765-016-012022-01-28C16284748780-1d6a99b39-f3a1-a426-e053-dadaa90af4c2a6e82d2a-09e2-28a8-e053-2a95a90aa2e5
74765-016-022022-01-28C16284748780-1d6a99b39-f3a1-a426-e053-dadaa90af4c2a6e82d2a-09e2-28a8-e053-2a95a90aa2e5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74765-016-01HAND SANITIZER100 mL in 1 BOTTLE, SPRAYSPRAY10016
74765-016-02HAND SANITIZER180 mL in 1 BOTTLE, SPRAYSPRAY18016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74765-016HAND SANITIZER (ALCOHOL) SPRAY [ZHEJIANG YIWU LIMEI COSMETICS CO.,LTD]16Legacy NDC, 2 package rows20200601_a6e82d2a-09e2-28a8-e053-2a95a90aa2e5.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
74765-01674765-016-01, 74765-016-02

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
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
a6e7c8da-278b-cd95-e053-2995a90a1784a6e82d2a-09e2-28a8-e053-2a95a90aa2e52020-05-30WarningsExact identifier
spl id: a6e7c8da-278b-cd95-e053-2995a90a1784
spl set id: a6e82d2a-09e2-28a8-e053-2a95a90aa2e5

Reported adverse events (FAERS/openFDA)#

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