75% alcohol hand sanitizer

Manufacturer
Narwhal, Inc. | Aogrand International Trade Corporation
Effective date
2023-02-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:54:04

Label at a glance#

Product75% alcohol hand sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

Hand sanitizer to help decrease bacteria on the skin when water, soap, and towel are not available. Recommended for repeated use.

Dosage and administration

Place enough product into your palms and thoroughly spread on both hands. Rub into skin until dry. Children under 6 years old must be supervised using this product. Avoid contact with eyes; in case of contact, flush with water.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic. Hand senitizer

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help decrease bacteria on the skin when water, soap, and towel are not available. Recommended for repeated use.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product into your palms and thoroughly spread on both hands.

Rub into skin until dry.

Children under 6 years old must be supervised using this product.

Avoid contact with eyes; in case of contact, flush with water.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

OTC - DO NOT USE SECTION

Do not apply around eyes. Do not use in ears & mouth.

OTC - STOP USE SECTION

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 immediately.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, triethanolamine, glycerin, water

OTHER SAFETY INFORMATION

Store below 110°F (43°C). May discolor certain fabrics or surfaces.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237 mL NDC: 78615-001-01

PDPPDP

500 mL NDC: 78615-001-02

PDPPDP

1000 mL NDC: 78615-001-03

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN4
1305100ethanol 0.75 ML/ML Topical GelSCD4
1305100ethanol 75 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78615-001-0175% alcohol hand sanitizer237 mL in 1 BOTTLEGEL2374
78615-001-0275% alcohol hand sanitizer500 mL in 1 BOTTLEGEL5004
78615-001-0375% alcohol hand sanitizer1000 mL in 1 BOTTLEGEL10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78615-00175% ALCOHOL HAND SANITIZER (ALCOHOL) GEL [NARWHAL, INC.]4Legacy NDC, 3 package rows20230214_a714b7a3-b1f4-2fbe-e053-2a95a90a3e48.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78615-00178615-001-01, 78615-001-02, 78615-001-03
74621-010

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
f48fa482-28a2-307f-e053-2995a90a3bcaa714b7a3-b1f4-2fbe-e053-2a95a90a3e482023-02-13WarningsExact identifier
spl id: f48fa482-28a2-307f-e053-2995a90a3bca
spl set id: a714b7a3-b1f4-2fbe-e053-2a95a90a3e48

Reported adverse events (FAERS/openFDA)#

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