FDA.reportPublic FDA data

Fresh Protect Gel Scented Pump

Manufacturer
Willspeed Technologies LLC
Effective date
2020-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:11

Label at a glance#

ProductFresh Protect Hand Sanitizer Bergamont Lime
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

- hand sanitizing to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

- Place enough product on hands to cover all surfaces - supervised children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Fresh Protect Gel Scented

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

- hand sanitizing to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Do not drink.

Flammable. Keep away from heat and flame

Do not use

OTC - DO NOT USE SECTION

on children less than 2 years of age. - on open skin wounds

When using this product

SPL UNCLASSIFIED SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

- Place enough product on hands to cover all surfaces - supervised children under 6 years of age when using this product to avoid swallowing.

Other information

SPL UNCLASSIFIED SECTION

- store at 15C to 30C (59F to 86F) - Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Ammonium Acryloyldimethltaurate/VP Copolymer, Citrus Sinensis Peel Oil expressed, Citrus Aurantium Bergamia (Bergamot Peel Oil, Citrus Aurantifolia (Lime) Oil, Aloe Barbadensis Leaf Juice, Niacinamide, Hydrogen Peroxide, Maltodextrin, Tocopheryl Acetate, DL-Panthenol

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fresh
PROTECT
HAND SANITIZER GEL
80% ALCOHOL
Non-sterile solution

PRINCIPAL DISPLAY PANEL Fresh PROTECT HAND SANITIZER GEL 80% ALCOHOL Non-sterile solutionPRINCIPAL DISPLAY PANEL Fresh PROTECT HAND SANITIZER GEL 80% ALCOHOL Non-sterile solution

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69243-0110-12022-01-28C16284748780-1d6a99b39-c72a-a426-e053-dadaa90af4c2Fresh Protect Gel Scented Pump
69243-0110-22022-01-28C16284748780-1d6a99b39-c72a-a426-e053-dadaa90af4c2Fresh Protect Gel Scented Pump
69243-0110-32022-01-28C16284748780-1d6a99b39-c72a-a426-e053-dadaa90af4c2Fresh Protect Gel Scented Pump
69243-0110-42022-01-28C16284748780-1d6a99b39-c72a-a426-e053-dadaa90af4c2Fresh Protect Gel Scented Pump
69243-0110-52022-01-28C16284748780-1d6a99b39-c72a-a426-e053-dadaa90af4c2Fresh Protect Gel Scented Pump
69243-0110-62022-01-28C16284748780-1d6a99b39-c72a-a426-e053-dadaa90af4c2Fresh Protect Gel Scented Pump
69243-0110-72022-01-28C16284748780-1d6a99b39-c72a-a426-e053-dadaa90af4c2Fresh Protect Gel Scented Pump
69243-0110-82022-01-28C16284748780-1d6a99b39-c72a-a426-e053-dadaa90af4c2Fresh Protect Gel Scented Pump

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69243-0110-1Fresh Protect Hand SanitizerBergamont Lime59 mL in 1 BOTTLE, PUMPGEL591
69243-0110-2Fresh Protect Hand SanitizerBergamont Lime118 mL in 1 BOTTLE, PUMPGEL1181
69243-0110-3Fresh Protect Hand SanitizerBergamont Lime237 mL in 1 BOTTLE, PUMPGEL2371
69243-0110-4Fresh Protect Hand SanitizerBergamont Lime355 mL in 1 BOTTLE, PUMPGEL3551
69243-0110-5Fresh Protect Hand SanitizerBergamont Lime473 mL in 1 BOTTLE, PUMPGEL4731
69243-0110-6Fresh Protect Hand SanitizerBergamont Lime946 mL in 1 BOTTLE, PUMPGEL9461
69243-0110-7Fresh Protect Hand SanitizerBergamont Lime1893 mL in 1 BOTTLE, PUMPGEL18931
69243-0110-8Fresh Protect Hand SanitizerBergamont Lime3785 mL in 1 BOTTLE, PUMPGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69243-0110FRESH PROTECT HAND SANITIZER BERGAMONT LIME (ALCOHOL) GEL [WILLSPEED TECHNOLOGIES LLC]1Legacy NDC, 8 package rows20200820_441f2f63-bbeb-402c-9b15-e42d640c5c8c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69243-011069243-0110-1, 69243-0110-2, 69243-0110-3, 69243-0110-4, 69243-0110-5, 69243-0110-6, 69243-0110-7, 69243-0110-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
ORANGE OIL TERPENELESSL8B7EWV9I7IACT
BERGAMOT OIL39W1PKE3JIIACT
LIME OILUZH29XGA8GIACT
ALOE VERA LEAFZY81Z83H0XIACT
NIACINAMIDE25X51I8RD4IACT
HYDROGEN PEROXIDEBBX060AN9VIACT
MALTODEXTRIN7CVR7L4A2DIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT

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
e4485f18-51d7-4295-97d7-3c46bf860a70441f2f63-bbeb-402c-9b15-e42d640c5c8c2020-08-18WarningsExact identifier
spl id: e4485f18-51d7-4295-97d7-3c46bf860a70
spl set id: 441f2f63-bbeb-402c-9b15-e42d640c5c8c

Reported adverse events (FAERS/openFDA)#

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