FDA.reportPublic FDA data

Natural Extensions Fragrance- Free Instant Hand Sanitizer

Manufacturer
Benco Dental
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:50

Label at a glance#

ProductNatural Extensions Fragrance- Free Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Dispense an adequate amount in your palm to cover all surfaces of hands completely. Rub hands together until dry. Supervise children in the use of this product.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Earth-friendly Natural Extensions Instant Hand Sanitizer contains natural ingredients like glycerin and 60% grain-based ethanol. Clinically proven to effectively kill 99.99% of a broad spectrum of microorganisms in 15 seconds without soap and water, it leaves hands feeling clean and refreshed even after frequent use.

  • Non-irritating formula
  • 95% Bio-based
  • Hydrates skin
  • Meets FDA protocol for Healthcare Personnel Handwash
  • CHG & latex compatible

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethanol 60%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire or flame.

Do not use in eyes. In case of eye contact, flush thoroughly with water and seek medical attention.

Stop use and ask a doctor if irritation and redness develop and persists 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 Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Dispense an adequate amount in your palm to cover all surfaces of hands completely.
  • Rub hands together until dry.
  • Supervise children in the use of this product.

Other Information

OTHER SAFETY INFORMATION

  • Do not store above 100 ºF (38 ºC)
  • May discolor some fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-GO-BENCO www.benco.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Label - 1 gallon Short Neck BottleProduct Label - 1 gallon Short Neck Bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581658ethanol 60 % Topical GelPSN3
581658ethanol 0.6 ML/ML Topical GelSCD3
581658ethanol 60 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66975-101-012022-12-08C16284748780-197449f38-ccbf-f6ea-e053-dbdaa90aa703Natural Extensions Fragrance-Free Instant Hand Sanitizer
66975-101-022022-12-08C16284748780-197449f38-ccbf-f6ea-e053-dbdaa90aa703Natural Extensions Fragrance-Free Instant Hand Sanitizer
66975-101-032022-12-08C16284748780-197449f38-ccbf-f6ea-e053-dbdaa90aa703Natural Extensions Fragrance-Free Instant Hand Sanitizer
66975-101-012019-11-13C16284748780-197449f38-ccbf-f6ea-e053-dbdaa90aa703Natural Extensions Fragrance-Free Instant Hand Sanitizer
66975-101-022019-11-13C16284748780-197449f38-ccbf-f6ea-e053-dbdaa90aa703Natural Extensions Fragrance-Free Instant Hand Sanitizer
66975-101-032019-11-13C16284748780-197449f38-ccbf-f6ea-e053-dbdaa90aa703Natural Extensions Fragrance-Free Instant Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-101-01Natural Extensions Fragrance- Free Instant Hand Sanitizer80 mL in 1 BOTTLE, DISPENSINGGEL803
66975-101-02Natural Extensions Fragrance- Free Instant Hand Sanitizer251 mL in 1 BOTTLE, PUMPGEL2513
66975-101-03Natural Extensions Fragrance- Free Instant Hand Sanitizer3785 mL in 1 JUGGEL37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66975-101NATURAL EXTENSIONS FRAGRANCE- FREE INSTANT HAND SANITIZER (ALCOHOL) GEL [BENCO DENTAL]3Current NDC, Legacy NDC, 3 package rows20231129_b1f10f16-8269-402a-9646-32dbfdef1ffc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M1
AlcoholACTIVE MOIETY3K9958V90M1
Carbomer 1342INACTIVE INGREDIENT809Y72KV361
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
TrolamineINACTIVE INGREDIENT9O3K93S3TK1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66975-10166975-101-01, 66975-101-02, 66975-101-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carbomer 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carbomer 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carbomer 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TrolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Carbomer 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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
Natural Extensions Fragrance- Free Instant Hand SanitizerALCOHOLBenco Dentalb1f10f16-8269-402a-9646-32dbfdef1ffc2023-11-28WarningsExact identifier
ndc (package): 66975-101-02
ndc (package): 66975-101-01
ndc (package): 66975-101-03
ndc (product): 66975-101
ndc11 (package): 66975010103
ndc11 (package): 66975010102
ndc11 (package): 66975010101
spl id: 0b39d4bb-1957-5128-e063-6394a90a4948
spl set id: b1f10f16-8269-402a-9646-32dbfdef1ffc

Reported adverse events (FAERS/openFDA)#

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