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

Bottle

Package Labeling:2000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2

Package Labeling:3.780ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
581662	ethanol 70 % Topical Gel	PSN	1
581662	ethanol 0.7 ML/ML Topical Gel	SCD	1
581662	ethanol 70 % Topical Gel	SY	1
581662	ethyl alcohol 70 % Topical Gel	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
74341-004-12	2022-01-28	C162847	48780-1	d6a99b39-ac10-a426-e053-dadaa90af4c2	Hand Sanitizer
74341-004-13	2022-01-28	C162847	48780-1	d6a99b39-ac10-a426-e053-dadaa90af4c2	Hand Sanitizer
74341-004-14	2022-01-28	C162847	48780-1	d6a99b39-ac10-a426-e053-dadaa90af4c2	Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
74341-004-12	Hand Sanitizer	1000 mL in 1 BOTTLE	GEL	1000	1
74341-004-13	Hand Sanitizer	2000 mL in 1 BOTTLE	GEL	2000	1
74341-004-14	Hand Sanitizer	3780 mL in 1 BOTTLE	GEL	3780	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
74341-004	HAND SANITIZER (ALCOHOL) GEL [NEWACME LLC]	1	Legacy NDC, 3 package rows	20200721_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.

Hand Sanitizer
ALCOHOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
PROPYLENE GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
74341-004	74341-004-12, 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
Name	UNII	Kind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
aadcc91d-2eb7-1d98-e053-2a95a90a5ecc			e7709e2c-231f-433c-bdf3-feddca2765b0	2020-07-20	Warnings	Exact 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.