FDA.reportPublic FDA data

5413 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 21:36:04

Label at a glance#

Product5413 hand sanitizer
Active ingredientALCOHOL
Label structure11 sections

Storage and handling

Store at room temperature 15° to 30°C (59° to 86°F).

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.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persists 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

Wet hands thoroughly with product, briskly rub hands together until dry. Supervise children in the use of this product.

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

Store at room temperature 15° to 30°C (59° to 86°F).

OTC - QUESTIONS SECTION

Questions? HOTLINE # 1-855-755 5346 NPN# 80062390

SPL UNCLASSIFIED SECTION

Made in China For Innovation Line Los Angeles,
CA 90066 Product # 5413

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5413 hand sanitizer5413 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
76138-11976138-119-01
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
94856f53-7daa-4eed-960f-ec8f3f614fec81ba36cf-e808-4954-bdf6-548cda13975b2023-02-14WarningsExact identifier
spl id: 94856f53-7daa-4eed-960f-ec8f3f614fec
spl set id: 81ba36cf-e808-4954-bdf6-548cda13975b

Reported adverse events (FAERS/openFDA)#

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