Beauty Formation Hand Sanitizer Individual

Manufacturer
Filo America
Effective date
2021-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:45:41

Label at a glance#

ProductBeauty Formation Hand Sanitizer Individual
Active ingredientALCOHOL
Label structure6 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 68% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Non-medical, for external use only.

Flammable. Keep away from the fire or flame.

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash appears and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Centre right away.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerol, Carbomer, Triethanolamine.

Direction

DOSAGE & ADMINISTRATION SECTION

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037039ethanol 68 % Topical GelPSN4
1037039ethanol 0.68 ML/ML Topical GelSCD4
1037039ethanol 68 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50435-104-012022-07-29C16284748780-1e4f33bdf-ab4f-d8a0-e053-dadaa90a6e4eBeauty Formation Hand Sanitizer Individual

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50435-104-01Beauty Formation Hand Sanitizer Individual5 mL in 1 PACKETGEL54
50435-104-01Beauty Formation Hand Sanitizer Individual10 in 1 PACKAGEGEL104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50435-104BEAUTY FORMATION HAND SANITIZER INDIVIDUAL (ALCOHOL) GEL [FILO AMERICA]4Legacy NDC, 2 package rows20211217_78bd839d-e4f1-4150-9034-5a32c7f6e9cc.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50435-10450435-104-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
d3455ce9-22e3-ca15-e053-2995a90adbd978bd839d-e4f1-4150-9034-5a32c7f6e9cc2021-12-16WarningsExact identifier
spl id: d3455ce9-22e3-ca15-e053-2995a90adbd9
spl set id: 78bd839d-e4f1-4150-9034-5a32c7f6e9cc

Reported adverse events (FAERS/openFDA)#

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