FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Fortress Expert Co., Ltd
Effective date
2020-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:05:51

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Wet hands thoroughly with product andand rub completelycovering hands Allow to dry without wiping Children under the age of 6 should use with adultsupervision Not recommended for infants

Storage and handling

Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Helps reduce bacteria that potentially can cause disease

Helps prevent Cross contamination by hand contact

Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire heat, or flame

Do not use near eyes

Incase of eye contact flush with water for 15 minutes

If irritation persists stop use of product and get medical attention

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental ingestion seek medical attention or contact a poison control center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product andand rub completelycovering hands

Allow to dry without wiping

Children under the age of 6 should use with adultsupervision

Not recommended for infants

Other information

STORAGE AND HANDLING SECTION

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, PEG-40 Hydrogenated Castor Oil, Carbomer, FragranceParfum), Triethanolamine, Triisopropanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122334455667788991010111112121313

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73549-001-012022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-022022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-032022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-042022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-052022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-062022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-072022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-082022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-092022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-102022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-112022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-122022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-132022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1
73549-001-142022-01-28C16284748780-1d6a99b39-d626-a426-e053-dadaa90af4c2a2f183a3-627e-2c2b-e053-2a95a90a56b1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73549-001-01Hand Sanitizer15 mL in 1 BOTTLEGEL151
73549-001-02Hand Sanitizer30 mL in 1 BOTTLEGEL301
73549-001-03Hand Sanitizer50 mL in 1 BOTTLEGEL501
73549-001-04Hand Sanitizer59 mL in 1 BOTTLEGEL591
73549-001-05Hand Sanitizer100 mL in 1 BOTTLEGEL1001
73549-001-06Hand Sanitizer150 mL in 1 BOTTLEGEL1501
73549-001-07Hand Sanitizer236 mL in 1 BOTTLEGEL2361
73549-001-08Hand Sanitizer250 mL in 1 BOTTLEGEL2501
73549-001-09Hand Sanitizer300 mL in 1 BOTTLEGEL3001
73549-001-10Hand Sanitizer330 mL in 1 BOTTLEGEL3301
73549-001-11Hand Sanitizer480 mL in 1 BOTTLEGEL4801
73549-001-12Hand Sanitizer500 mL in 1 BOTTLEGEL5001
73549-001-13Hand Sanitizer944 mL in 1 BOTTLEGEL9441
73549-001-14Hand Sanitizer950 mL in 1 BOTTLEGEL9501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73549-001HAND SANITIZER GEL [FORTRESS EXPERT CO., LTD]1Legacy NDC, 14 package rows20200411_a2f183a3-627e-2c2b-e053-2a95a90a56b1.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73549-00173549-001-01, 73549-001-02, 73549-001-03, 73549-001-04, 73549-001-05, 73549-001-06, 73549-001-07, 73549-001-08, 73549-001-09, 73549-001-10, 73549-001-11, 73549-001-12, 73549-001-13, 73549-001-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIISOPROPANOLAMINEW9EN9DLM98IACT
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a2f0cb79-f137-64e9-e053-2995a90ad44ca2f183a3-627e-2c2b-e053-2a95a90a56b12020-04-08WarningsExact identifier
spl id: a2f0cb79-f137-64e9-e053-2995a90ad44c
spl set id: a2f183a3-627e-2c2b-e053-2a95a90a56b1

Reported adverse events (FAERS/openFDA)#

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