FDA.reportPublic FDA data

5257 Hand Sanitizer

Manufacturer
Innovation Specialties
Effective date
2023-02-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:36:06

Label at a glance#

Product5257 Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Ethyl alcohol 62%.

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

WARNINGS SECTION

Warnings

Flammable, keep away from fire or flame.For external use only.

When using this product Avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor If redness or irritation 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.

DOSAGE & ADMINISTRATION SECTION

Directions

Spread on both hands, rub in, let dry.

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions? Call 1-855-755-5346

SPL UNCLASSIFIED SECTION

Made in China for Innovation Line Culver City, CA 90230

NPN# 80062390

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5257 Hand Sanitizer5257 Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76138-12176138-121-03
70412-110

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
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial Hand SanitizerETHYL ALCOHOLZhejiang Ayan Biotech Co.,Ltd.c7e94ccb-5ec4-4e35-b8d3-8e1f066f4bb82023-11-06WarningsExact identifier
ndc (product): 70412-110
27ebc85f-2173-42fb-8864-31b15425a9afc62f5213-3450-44c2-982c-1969a443d7ee2023-02-14WarningsExact identifier
spl id: 27ebc85f-2173-42fb-8864-31b15425a9af
spl set id: c62f5213-3450-44c2-982c-1969a443d7ee

Reported adverse events (FAERS/openFDA)#

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