FDA.reportPublic FDA data

Acqua Aroma Hand Sanitizer Gel

Manufacturer
Smell It Industria e Comercio Ltda | Acqua Aroma US LLC
Effective date
2020-06-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:16:27

Label at a glance#

ProductAcqua Aroma Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure16 sections

Dosage and administration

Rub into hands until dry.

Storage and handling

Store below 104°F (40°C). May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Ethyl Alcohol 70% v/v

Purpose:

OTC - PURPOSE SECTION

Purpose: Antiseptic

Use

INDICATIONS & USAGE SECTION

Decreases UseUsebacteria on hands.

Warnings

WARNINGS SECTION

Flammable. Keep away from flame or high heat.


For external use only.


(For 1.0 FL OZ) Warnings:

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

(For 12.9 FL OZ) Warnings:

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse with water.


Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop or increase.


(For 1.0 FL OZ) Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

(For 12.9 FL OZ) Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out reach of Children. Children under 6 year old should be supervised when using it. If swallowed, get medical help or contact a Poison Control Center right away.

Other Information:

STORAGE AND HANDLING SECTION

Store below 104°F (40°C). May discolor certain fabrics or surfaces.

Directions

DOSAGE & ADMINISTRATION SECTION

Rub into hands until dry.

(For 1.0 FL OZ) Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water (Aqua), Methyl Gluceth-20, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Aminomethyl Propanol, Mannitol, Cellulose, Citronellol, Linalool, Alpha-isomethyl Ionone, Coumarin, CI 77492, D-limonene, Geraniol, Tocopheryl Acetate, Hydroxypropyl Methylcellulose.

(For 12.9 FL OZ) Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua), Acrylates C10-30 Alkyl Acrylate Crosspolymer, Methyl Gluceth-20, Fragrance (Parfum), Aminomethyl Propanol, Mannitol, Cellulose, Citronellol, Linalool, Alpha-isomethyl Ionone, Acrylates Copolymer, Coumarin, CI 77492, Hydroxypropylcellulose, Mica, CI 77891, D-limonene, Geraniol, Hydroxypropyl Methylcellulose, Triethyl Citrate, Acrylate Ammonium Methacrylate Copolymer, CI 77491, Caprylyl Capryl Glucoside, Caprylic Capric Triglyceride, Lauryl Glucoside, Talc, Tocopheryl Acetate.

Questions

OTC - QUESTIONS SECTION

Questions: 1-844-636-7504 | CustomerService@acquaaroma.com

(For 1.0 OZ) Primary Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acqua AromaAcqua AromaNDC Number Acqua Aroma With Vitamin E microspheres Hand Sanitizer Gel 1.0 FL OZ (30ML) Kills 99.9% of common bacteria

(For 12.9 OZ) Primary Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acqua AromaAcqua AromaAcqua Aroma The Scent of Your Home NDC Number With Vitamin E microspheres Hand Sanitizer Gel 12.9 FL OZ (380ML) Kills 99.9% of common bacteria

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70848-410-302022-01-28C16284748780-19d75b9d0-41b3-f424-e053-dadaa90a57ce3ae64b5a-7aee-6239-e054-00144ff88e88
70848-413-802022-01-28C16284748780-19d75b9d0-41b3-f424-e053-dadaa90a57ce3ae64b5a-7aee-6239-e054-00144ff88e88
70848-410-302020-06-08C16284748780-19d75b9d0-41b3-f424-e053-dadaa90a57ce3ae64b5a-7aee-6239-e054-00144ff88e88
70848-413-802020-06-08C16284748780-19d75b9d0-41b3-f424-e053-dadaa90a57ce3ae64b5a-7aee-6239-e054-00144ff88e88
70848-410-302020-01-31C16284748780-19d75b9d0-41b3-f424-e053-dadaa90a57ce3ae64b5a-7aee-6239-e054-00144ff88e88
70848-413-802020-01-31C16284748780-19d75b9d0-41b3-f424-e053-dadaa90a57ce3ae64b5a-7aee-6239-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70848-410-30Acqua Aroma Hand Sanitizer Gel30 mL in 1 BOTTLE, PLASTICGEL302
70848-413-80Acqua Aroma Hand Sanitizer Gel380 mL in 1 BOTTLE, PLASTICGEL3802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70848-410ACQUA AROMA HAND SANITIZER GEL (ALCOHOL) GEL [SMELL IT INDUSTRIA E COMERCIO LTDA]2Legacy NDC, 1 package rows20200609_3ae64b5a-7aee-6239-e054-00144ff88e88.zip
70848-413ACQUA AROMA HAND SANITIZER GEL (ALCOHOL) GEL [SMELL IT INDUSTRIA E COMERCIO LTDA]2Legacy NDC, 1 package rows20200609_3ae64b5a-7aee-6239-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70848-41070848-410-30
70848-41370848-413-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMINOMETHYLPROPANOLLU49E6626QIACT
POWDERED CELLULOSESMD1X3XO9MIACT
MANNITOL3OWL53L36AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
METHYL GLUCETH-20J3QD0LD11PIACT
HYPROMELLOSES3NXW29V3WOIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER39DK5WQ2PRIACT
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMERR0R8I3X29JIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TALC7SEV7J4R1UIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
POWDERED CELLULOSESMD1X3XO9MIACT
MANNITOL3OWL53L36AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
METHYL GLUCETH-20J3QD0LD11PIACT
HYPROMELLOSES3NXW29V3WOIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
FERRIC OXIDE RED1K09F3G675IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
MICAV8A1AW0880IACT
TRIETHYL CITRATE8Z96QXD6UMIACT

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
a76d15df-4415-887b-e053-2a95a90a888c3ae64b5a-7aee-6239-e054-00144ff88e882020-06-06WarningsExact identifier
spl id: a76d15df-4415-887b-e053-2a95a90a888c
spl set id: 3ae64b5a-7aee-6239-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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