FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Newacme llc | Zhejiang Ayan Biotech Co.,Ltd.
Effective date
2022-01-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:26

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Place a palmful (5 grams) of product in one hand.  Spread on both hands and rub into skin until dry (approximately 1 to 2 minutes).

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing 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 a palmful (5 grams) of product in one hand. 
  • Spread on both hands and rub into skin until dry (approximately 1 to 2 minutes).

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: 15 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 53 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: 60 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling: 473 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74341-194-152024-01-30C16284748780-11030e365-61c7-111a-e063-dadaa90a10e2Hand Sanitizer
74341-194-532024-01-30C16284748780-11030e365-61c7-111a-e063-dadaa90a10e2Hand Sanitizer
74341-194-602024-01-30C16284748780-11030e365-61c7-111a-e063-dadaa90a10e2Hand Sanitizer
74341-194-732024-01-30C16284748780-11030e365-61c7-111a-e063-dadaa90a10e2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74341-194-15Hand Sanitizer15 mL in 1 BOTTLEGEL153
74341-194-53Hand Sanitizer53 mL in 1 BOTTLEGEL533
74341-194-60Hand Sanitizer60 mL in 1 BOTTLEGEL603
74341-194-73Hand Sanitizer473 mL in 1 BOTTLEGEL4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74341-194HAND SANITIZER (ALCOHOL) GEL [NEWACME LLC]3Legacy NDC, 4 package rows20220123_b60ace2f-bdf2-49cd-bd76-6cced71704f0.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
74341-19474341-194-15, 74341-194-53, 74341-194-60, 74341-194-73

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 · 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
d61e6cfd-1b20-513f-e053-2995a90ae219b60ace2f-bdf2-49cd-bd76-6cced71704f02022-01-21WarningsExact identifier
spl id: d61e6cfd-1b20-513f-e053-2995a90ae219
spl set id: b60ace2f-bdf2-49cd-bd76-6cced71704f0

Reported adverse events (FAERS/openFDA)#

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