FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Newacme LLC | SHANDISHI Biological Technology Co., Ltd.
Effective date
2020-07-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:06

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

For Hand Sanitizing.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping For children under 6 use only under adult Supervision. Not recommended for infants.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

For Hand Sanitizing.

Warnings:

WARNINGS SECTION

For external use only-hands.

Flammable: Keep away from heat and flame.

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • Avoid contact with broken skin.
  • Do not inhale or ingest.

Stop use and ask a doctor

OTC - STOP USE SECTION

If skin irritation develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or call a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping

  • For children under 6 use only under adult Supervision.
  • Not recommended for infants.

Other information:

SPL UNCLASSIFIED SECTION

Do not store above 105°F.

  • May discolor some fabrics.
  • Harmful to wood finishes and plastics.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Package Labeling:1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:2000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:3.780ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

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
74341-004-122022-01-28C16284748780-1d6a99b39-ac10-a426-e053-dadaa90af4c2Hand Sanitizer
74341-004-132022-01-28C16284748780-1d6a99b39-ac10-a426-e053-dadaa90af4c2Hand Sanitizer
74341-004-142022-01-28C16284748780-1d6a99b39-ac10-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74341-004-12Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
74341-004-13Hand Sanitizer2000 mL in 1 BOTTLEGEL20001
74341-004-14Hand Sanitizer3780 mL in 1 BOTTLEGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74341-004HAND SANITIZER (ALCOHOL) GEL [NEWACME LLC]1Legacy NDC, 3 package rows20200721_e7709e2c-231f-433c-bdf3-feddca2765b0.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74341-00474341-004-12, 74341-004-13, 74341-004-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
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
aadcc91d-2eb7-1d98-e053-2a95a90a5ecce7709e2c-231f-433c-bdf3-feddca2765b02020-07-20WarningsExact identifier
spl id: aadcc91d-2eb7-1d98-e053-2a95a90a5ecc
spl set id: e7709e2c-231f-433c-bdf3-feddca2765b0

Reported adverse events (FAERS/openFDA)#

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