FDA.reportPublic FDA data

ONE STEP

Manufacturer
BELVEDERE INTERNATIONAL INC.
Effective date
2020-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:37

Label at a glance#

ProductONE STEP
Active ingredientALCOHOL
Label structure13 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin

Dosage and administration

Place enough product in your palm to thoroughly cover your hands and rub hands together until dry. Children under 6 years should be supervised when using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%v/v .........Antiseptic

Uses

OTC - PURPOSE SECTION

Hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from source of heat, fire or flame.

For external use only.

OTC - STOP USE SECTION

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

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

Place enough product in your palm to thoroughly cover your hands and rub hands together until dry.

Children under 6 years should be supervised when using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Ext. Violet 2 (CI 60730), Fragrance (Parfum), Polysorbate 20, Tetrahydroxypropyl Ethylenediamine, Water (Aqua).

OTHER SAFETY INFORMATION

Store at a temperature below 110 F (43 oC)

may discolor certain fabrics or surfaces.

DOSAGE & ADMINISTRATION SECTION

Children under 6 years should be supervised when using this product

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

One step 60mlOne step 60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

One step 473 mlOne step 473 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

One Step 236mlOne Step 236ml

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
60742-400-012022-01-28C16284748780-1d6a99b39-edbe-a426-e053-dadaa90af4c2ONE STEP HAND SANITIZER
60742-400-032022-01-28C16284748780-1d6a99b39-edbe-a426-e053-dadaa90af4c2ONE STEP HAND SANITIZER
60742-400-042022-01-28C16284748780-1d6a99b39-edbe-a426-e053-dadaa90af4c2ONE STEP HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60742-400-01ONE STEP60 mL in 1 BOTTLEGEL601
60742-400-03ONE STEP473 mL in 1 BOTTLE, PUMPGEL4731
60742-400-04ONE STEP236 mL in 1 BOTTLE, PUMPGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60742-400ONE STEP (HAND SANITIZER) GEL [BELVEDERE INTERNATIONAL INC.]1Legacy NDC, 3 package rows20200205_9daee683-1c5f-f8c8-e053-2a95a90a3388.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60742-40060742-400-03, 60742-400-01, 60742-400-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETOLQ4R969U9FRIACT
CARBOMER 9404Q93RCW27EIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYSORBATE 207T1F30V5YHIACT
ALCOHOL3K9958V90MACTIB
EXT. D&C VIOLET NO. 2G5UX3K0728IACT
WATER059QF0KO0RIACT

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
9daee683-1c60-f8c8-e053-2a95a90a33889daee683-1c5f-f8c8-e053-2a95a90a33882020-02-03WarningsExact identifier
spl id: 9daee683-1c60-f8c8-e053-2a95a90a3388
spl set id: 9daee683-1c5f-f8c8-e053-2a95a90a3388

Reported adverse events (FAERS/openFDA)#

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