FDA.reportPublic FDA data

Bklen Hands Sanitizer

Manufacturer
Garflo Inc
Effective date
2020-11-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:54

Label at a glance#

ProductBklen Hands Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

To decrease bacteria on the skin that could cause disease. Recommended for repeated use

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% 

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease. Recommended for repeated use

Warnings:

WARNINGS SECTION

For external use only: Hands/ Flammable, keep away from fire or flame.

When using this product:

OTC - WHEN USING SECTION

Keep out of eyes. In case of contact with eyes, flush thoroughly with water/ Avoid contact with broken skin/ Do not inhale or ingest.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Irritation and redness occurs/ Condition persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Other information:

SPL UNCLASSIFIED SECTION

Do not store above 105° F. May discolor some fabrics. Harmful to wood finishes and plastics

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, carbomer, aloe, glycerin, isopropyl myristate, tocopheryl acetate

Questions?

OTC - QUESTIONS SECTION

Visit www.bklen.com / contact@bklen.com

Package Labeling:59.1ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:236.5ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:473.1ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:946.3ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

Package Labeling:3784.6ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle5Bottle5

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
81081-000-012022-01-28C16284748780-1d6a99b39-e63e-a426-e053-dadaa90af4c2Bklen Hands Sanitizer
81081-000-022022-01-28C16284748780-1d6a99b39-e63e-a426-e053-dadaa90af4c2Bklen Hands Sanitizer
81081-000-032022-01-28C16284748780-1d6a99b39-e63e-a426-e053-dadaa90af4c2Bklen Hands Sanitizer
81081-000-042022-01-28C16284748780-1d6a99b39-e63e-a426-e053-dadaa90af4c2Bklen Hands Sanitizer
81081-000-052022-01-28C16284748780-1d6a99b39-e63e-a426-e053-dadaa90af4c2Bklen Hands Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81081-000-01Bklen Hands Sanitizer59.1 mL in 1 BOTTLEGEL59.11
81081-000-02Bklen Hands Sanitizer236.5 mL in 1 BOTTLEGEL236.51
81081-000-03Bklen Hands Sanitizer473.1 mL in 1 BOTTLEGEL473.11
81081-000-04Bklen Hands Sanitizer946.3 mL in 1 BOTTLEGEL946.31
81081-000-05Bklen Hands Sanitizer3784.6 mL in 1 BOTTLEGEL3784.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81081-000BKLEN HANDS SANITIZER (ALCOHOL) GEL [GARFLO INC]1Legacy NDC, 5 package rows20201119_b462b873-7466-cec3-e053-2995a90aa12f.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81081-00081081-000-01, 81081-000-02, 81081-000-03, 81081-000-04, 81081-000-05

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
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB

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
b462b873-7467-cec3-e053-2995a90aa12fb462b873-7466-cec3-e053-2995a90aa12f2020-11-18WarningsExact identifier
spl id: b462b873-7467-cec3-e053-2995a90aa12f
spl set id: b462b873-7466-cec3-e053-2995a90aa12f

Reported adverse events (FAERS/openFDA)#

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