FDA.reportPublic FDA data

Above Hand Sani Antiseptic

Manufacturer
Baston Industria De Aerossols Ltda
Effective date
2020-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:15

Label at a glance#

ProductAbove Hand Sani Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

Hand sanitizer to help decrease bacteria on the skin. Recommended for repeated use

Dosage and administration

Shake well before using. Put a small amount in your palm and rub hands together briskly until dry, always holding the container in an upright position. No rinsing required. No towels needed. 

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride (0,10%)

Purpose

OTC - PURPOSE SECTION

antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help decrease bacteria on the skin. Recommended for repeated use

Warnings

WARNINGS SECTION

FLAMMABLE. DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING. CAN CAUSE SERIOUS INJURY OR DEATH

  • KEEP AWAY FROM FACE AND MOUTH TO AVOID CONTACT 

DO NOT USE

OTC - DO NOT USE SECTION

IN OR NEAR THE EYES. IN CASE OF CONTACT WITH EYES, RINSE THOROUGHLY WITH WATER. CONTENTS UNDER PRESSURE. DO NOT
PUNCTURE OR INCINERATE. DO NOT EXPOSE TO HEAT, SUNLIGHT OR STORE AT TEMPERATURES ABOVE 120°F/50°C OR IN ENCLOSED PLACES THAT COULD OVERHEAT

  • DO NOT USE ON BROKEN SKIN.

STOP USE IF

OTC - STOP USE SECTION

RASH OR IRRITATION OCCURS. GET MEDICAL ATTENTION IMMEDIATELY

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

AND ANIMALS USE ONLY AS DIRECTED. FOR EXTERNAL USE ONLY. IF SWALLOWED, DO NOT INDUCE VOMITING. CONSULT YOUR HEALTHCARE PROVIDER IMMEDIATELY DO NOT LEAVE THE AEROSOL CONTAINER IN A VEHICLE. RISK OF LEAKAGE AND EXPLOSION. CONTAINER MATERIAL: ALUMINUM BATCH AND EXPIRATION ON THE BOTTOM OF THE CONTAINER.

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before using. Put a small amount in your palm and rub hands together briskly until dry, always holding the container in an upright position. No rinsing required. No towels needed. 

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA / ALCOHOL / BUTANE / PROPANE / GLYCERIN / ISOBUTANE / COCAMIDOPROPYL BETAINE / TOCOPHERYL ACETATE / PEG-12 DIMETHICONE / IMIDAZOLIDINYL UREA / SODIUM BENZOATE / PROPYLENE GLYCOL / ALOE BARBADENSIS EXTRACT / SODIUM CHLORIDE / MELALEUCA ALTERNIFOLIA LEAF OIL / EUGENIA CARYOPHYLLUS LEAF OIL / SODIUM CITRATE / BENZOIC ACID / CITRIC ACID / PARFUM (BENZYL BENZOATE / CITRAL / CITRONELLOL /GERANIOL / LIMONENE / HEXYL CINNAMAL / LINALOOL).

Questions?

OTC - QUESTIONS SECTION

e-mail support@myspray.group or call: +1 (305) 677-5030

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN1
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD1
1038799benzalkonium chloride 0.1 % Topical FoamSY1

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
73306-6001-12023-01-30C16284748780-1f386c649-d98c-0266-e053-dadaa90a7c1aAbove Hand Sani Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73306-6001-1Above Hand Sani Antiseptic130 g in 1 CANAEROSOL, FOAM1301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73306-6001ABOVE HAND SANI ANTISEPTIC (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [BASTON INDUSTRIA DE AEROSSOLS LTDA]1Legacy NDC, 1 package rows20200820_ad4035c0-6792-7082-e053-2995a90a7d94.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73306-600173306-6001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BUTANE6LV4FOR43RIACT
PROPANET75W9911L6IACT
GLYCERINPDC6A3C0OXIACT
ISOBUTANEBXR49TP611IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG-12 DIMETHICONEZEL54N6W95IACT
IMIDUREAM629807ATLIACT
SODIUM BENZOATEOJ245FE5EUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CHLORIDE451W47IQ8XIACT
TEA TREE OILVIF565UC2GIACT
SODIUM CITRATE1Q73Q2JULRIACT
BENZOIC ACID8SKN0B0MIMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZYL BENZOATEN863NB338GIACT
CITRALT7EU0O9VPPIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
GERANIOLL837108USYIACT
LIMONENE, (+)-GFD7C86Q1WIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
LINALOOL, (+/-)-D81QY6I88EIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
ad402dcb-e50e-4e00-e053-2a95a90a5ba6ad4035c0-6792-7082-e053-2995a90a7d942020-08-19WarningsExact identifier
spl id: ad402dcb-e50e-4e00-e053-2a95a90a5ba6
spl set id: ad4035c0-6792-7082-e053-2995a90a7d94

Reported adverse events (FAERS/openFDA)#

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