FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Newacme LLC | SHANDISHI Biological Technology Co., Ltd.
Effective date
2020-07-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:21:32

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Place enough product in your palm to thoroughly cover your hands. Children under 6 year of age should be supervised when using this product. Rub hands together briskly until dry. Not recommended for infants.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria ont he skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For External Use Only

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if skin irritation or rash develops and continues for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact your Poison Control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands.
  • Children under 6 year of age should be supervised when using this product.
  • Rub hands together briskly until dry.
  • Not recommended for infants.

Other information

SPL UNCLASSIFIED SECTION

  • Do not store above 105°F.
  • Discolor some fabrics.
  • Harmful to wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera leaf juice, Glycerin, Fragrance(Parfum), Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74341-003-032022-05-10C16284748780-1d6a99b39-4284-a426-e053-dadaa90af4c2Hand Sanitizer
74341-003-032022-01-28C16284748780-1d6a99b39-4284-a426-e053-dadaa90af4c2Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74341-00374341-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
d6a6f98e-db89-c8e8-e053-2a95a90ad51659690973-ee33-4800-8357-e5ef27b2d24c2022-01-28WarningsExact identifier
spl set id: 59690973-ee33-4800-8357-e5ef27b2d24c

Reported adverse events (FAERS/openFDA)#

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