FDA.reportPublic FDA data

BioSalut Hand Sanitizer Advanced

Manufacturer
Brazilian Hair Llc | PHITOTERAPHIA BIOFITOGENIA LABORATORIAL BIOTA LTDA
Effective date
2020-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:24

Label at a glance#

ProductBioSalut Hand Sanitizer Advanced
Active ingredientALCOHOL
Label structure9 sections

Storage and handling

Other Information • Do not store above 105°F (43°C)  • May discolor some fabrics and surfaces.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Uses • Decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from heat and flame.

When using this product, avoid contact with eye. In case of contact, flush with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions• Wet hands thoroughly with product and allow to dry. • Children under 6 years of age, use only under adult supervision.

STORAGE AND HANDLING SECTION

Other Information • Do not store above 105°F (43°C) • May discolor some fabrics and surfaces.

INACTIVE INGREDIENT SECTION

Inactive Ingredients AQUA, PROPYLENE GLYCOL, GLYCERIN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PARFUM, AMINOMETHYL PROPANOL, CINNAMYL ALCOHOL, HEXYL CINNAMAL, D-LIMONENE, COUMARIN, BENZYL SALICYLATE, GERANIOL, ALOE BARBADENSIS LEAF EXTRACT, SORBITOL, POTASSIUM SORBATE, SODIUM BENZOATE. AFE: 2.02.100-5

SPL UNCLASSIFIED SECTION

KILLS 99.9% OF GERMS

Disinfects while moisturizes, leaving hands feeling refreshed.

Manufactured by : Phitoteraphia Biofitogenia Laboratorial Biota

Ltda Rua Maria de Andrade 79A . CEP 26261 - 200 Nova Iguaçu/RJ. CNPJ:

00.104.603/0001-33. Brazilian Industry • Téc. Resp:

Eni Figueiredo CRQ III 03212976 • Imported and distributed in USA by: Brazilian Hair LLC. 1275

Bloomfield Ave. Bldg. 7 Unit 48 Fairfield, NJ 07004.

Ph: +1 800 519 2946 -info@embellezeusa.com - www.novexhaircare.com Origin/Origen: Brazil

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackagingPackagingPackaging

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
75753-300-012022-01-28C16284748780-1d6a99b39-60e5-a426-e053-dadaa90af4c2EMBELLEZE BioSalut Hand Sanitizer ADVANCED
75753-300-092022-01-28C16284748780-1d6a99b39-60e5-a426-e053-dadaa90af4c2EMBELLEZE BioSalut Hand Sanitizer ADVANCED

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75753-300-01BioSalut Hand Sanitizer Advanced300 mL in 1 BOTTLE, PLASTICGEL3001
75753-300-09BioSalut Hand Sanitizer Advanced140 mL in 1 BOTTLE, PLASTICGEL1401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75753-300BIOSALUT HAND SANITIZER ADVANCED (ALCOHOL) GEL [BRAZILIAN HAIR LLC]1Legacy NDC, 2 package rows20200916_821d4be7-20d1-44bb-bc05-87acc8d9782c.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75753-30075753-300-09, 75753-300-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CINNAMYL ALCOHOLSS8YOP444FIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
LIMONENE, (+)-GFD7C86Q1WIACT
COUMARINA4VZ22K1WTIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
GERANIOLL837108USYIACT
ALOE VERA LEAFZY81Z83H0XIACT
SORBITOL506T60A25RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT

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
a390e28b-356d-44ba-bf20-9a612ba90ed9821d4be7-20d1-44bb-bc05-87acc8d9782c2020-09-14WarningsExact identifier
spl id: a390e28b-356d-44ba-bf20-9a612ba90ed9
spl set id: 821d4be7-20d1-44bb-bc05-87acc8d9782c

Reported adverse events (FAERS/openFDA)#

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