FDA.reportPublic FDA data

Instant Unscented Hand Sanitizer with aloe vera Advanced

Manufacturer
Earths Amenities | DDI Multinacional, S.A. de C.V.
Effective date
2020-04-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:08:32

Label at a glance#

ProductInstant Unscented Hand Sanitizer with aloe vera Advanced
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Antiseptic

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

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) :

  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. Caprylyl Glycol
  6. Decylene Glycol
  7. Benzoic Acid
  8. Carbomer
  9. Triethanolamine

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Uses

OTC - PURPOSE SECTION

Antiseptic

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

When using this product 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

Keep out of reach of children. 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, aloe barbadensis (aloe vera extract), triethanolamine, glycerin, caprylyl glycol, decylene glycol, benzoic acid, carbomer

INDICATIONS & USAGE SECTION

To help reduce bacteria on the skin

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 74949-002-60

60ml60ml

250 mL NDC: 74949-002-25

250ml250ml

495 mL NDC: 74949-002-49

495ml495ml

20000 mL NDC: 74949-002-20

20lt20lt

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN2
582753ethanol 0.7 ML/ML Topical SolutionSCD2
582753ethanol 70 % Topical SolutionSY2
582753ethyl alcohol 70 % Topical SolutionSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860003628614GTIN-13: 0860003628614
EAN-13: 0860003628614
GTIN-12: 860003628614
UPC-A: 860003628614
GTIN storage (14 digits): 00860003628614		DDI-EARTHS AMENITIES 250 ML.jpg
BarcodeEAN-130860003628676GTIN-13: 0860003628676
EAN-13: 0860003628676
GTIN-12: 860003628676
UPC-A: 860003628676
GTIN storage (14 digits): 00860003628676		DDI-EARTHS AMENITIES 495 ML.jpg
BarcodeEAN-130860003628683GTIN-13: 0860003628683
EAN-13: 0860003628683
GTIN-12: 860003628683
UPC-A: 860003628683
GTIN storage (14 digits): 00860003628683		DDI-EARTHS AMENITIES 60 ML.PDF.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74949-002-202022-01-28C16284748780-1d6a99b39-3bb3-a426-e053-dadaa90af4c2a3d31e3b-bf7b-ae57-e053-2a95a90a86ae
74949-002-252022-01-28C16284748780-1d6a99b39-3bb3-a426-e053-dadaa90af4c2a3d31e3b-bf7b-ae57-e053-2a95a90a86ae
74949-002-492022-01-28C16284748780-1d6a99b39-3bb3-a426-e053-dadaa90af4c2a3d31e3b-bf7b-ae57-e053-2a95a90a86ae
74949-002-602022-01-28C16284748780-1d6a99b39-3bb3-a426-e053-dadaa90af4c2a3d31e3b-bf7b-ae57-e053-2a95a90a86ae

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74949-002-20Instant Unscented Hand Sanitizer with aloe vera Advanced20000 mL in 1 BOTTLELIQUID200002
74949-002-25Instant Unscented Hand Sanitizer with aloe vera Advanced250 mL in 1 BOTTLELIQUID2502
74949-002-49Instant Unscented Hand Sanitizer with aloe vera Advanced495 mL in 1 BOTTLELIQUID4952
74949-002-60Instant Unscented Hand Sanitizer with aloe vera Advanced60 mL in 1 BOTTLELIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74949-002INSTANT UNSCENTED HAND SANITIZER WITH ALOE VERA ADVANCED (ALCOHOL) LIQUID [EARTHS AMENITIES]2Legacy NDC, 4 package rows20200429_a3d31e3b-bf7b-ae57-e053-2a95a90a86ae.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74949-00274949-002-60, 74949-002-25, 74949-002-49, 74949-002-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA FLOWER575DY8C1ERIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
BENZOIC ACID8SKN0B0MIMIACT
CARBOMER 9404Q93RCW27EIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DECYLENE GLYCOLS57M60MI88IACT

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
a45bf2fd-98cd-7b30-e053-2a95a90ac00ca3d31e3b-bf7b-ae57-e053-2a95a90a86ae2020-04-28WarningsExact identifier
spl id: a45bf2fd-98cd-7b30-e053-2a95a90ac00c
spl set id: a3d31e3b-bf7b-ae57-e053-2a95a90a86ae

Reported adverse events (FAERS/openFDA)#

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