FDA.reportPublic FDA data

Instant Hand Sanitizer

Manufacturer
Earths Amenities | Desarrollo Tecnológico Laser, S.A. de C.V.
Effective date
2020-04-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:08:14

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times a day.

Storage and handling

Store below 73.4F (23C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the OTC Monograph Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.

The hand sanitizer is manufactured using

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerin
  3. Aloe Vera Extract
  4. Water
  5. Carbomer
  6. Aminomethyl Propanol

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame

OTC - WHEN USING SECTION

Do not use on damaged or broken skin. Do not leave near fire. Wash with enough water, if it gets into eyes. Do not drink.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation or redness develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times a day.

Other information

STORAGE AND HANDLING SECTION

Store below 73.4F (23C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, aloe vera extract, carbomer, aminomethyl propanol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 74949-001-60

60Ml60Ml

250 mL NDC: 74949-001-25 Label250Label250

495 mL NDC: 74949-001-49

Label495Label495

1L NDC: 74949-001-01

GLLabel 1LGLLabel 1L

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN3
582753ethanol 0.7 ML/ML Topical SolutionSCD3
582753ethanol 70 % Topical SolutionSY3
582753ethyl alcohol 70 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74949-001-012022-01-28C16284748780-1d6a99b39-befc-a426-e053-dadaa90af4c2a2e129b9-5796-6c25-e053-2995a90a85aa
74949-001-252022-01-28C16284748780-1d6a99b39-befc-a426-e053-dadaa90af4c2a2e129b9-5796-6c25-e053-2995a90a85aa
74949-001-492022-01-28C16284748780-1d6a99b39-befc-a426-e053-dadaa90af4c2a2e129b9-5796-6c25-e053-2995a90a85aa
74949-001-602022-01-28C16284748780-1d6a99b39-befc-a426-e053-dadaa90af4c2a2e129b9-5796-6c25-e053-2995a90a85aa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74949-001-01Instant Hand Sanitizer1000 mL in 1 BOTTLELIQUID10003
74949-001-25Instant Hand Sanitizer250 mL in 1 BOTTLELIQUID2503
74949-001-49Instant Hand Sanitizer495 mL in 1 BOTTLELIQUID4953
74949-001-60Instant Hand Sanitizer60 mL in 1 BOTTLELIQUID603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74949-001INSTANT HAND SANITIZER (ALCOHOL) LIQUID [EARTHS AMENITIES]3Legacy NDC, 4 package rows20200428_a2e129b9-5796-6c25-e053-2995a90a85aa.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
74949-00174949-001-60, 74949-001-25, 74949-001-49, 74949-001-01

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
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
ALOE VERA FLOWER575DY8C1ERIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a44a4d92-67f2-f976-e053-2995a90aae9ca2e129b9-5796-6c25-e053-2995a90a85aa2020-04-27WarningsExact identifier
spl id: a44a4d92-67f2-f976-e053-2995a90aae9c
spl set id: a2e129b9-5796-6c25-e053-2995a90a85aa

Reported adverse events (FAERS/openFDA)#

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