Insta-Shield Hand Sanitizer Gel

Manufacturer
Four Fathers Distillery LLC
Effective date
2020-10-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:19

Label at a glance#

ProductInsta-Shield Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Place enough product on hands to cover all surfaces, rub together until dry. Supervise children under 6 years of age to prevent swallowing.

Storage and handling

Store between 59-86°F. DO NOT store in heat above 105°F. May discolor some fabrics. Harmful to wood surfaces and plastics. 

Label contents#

Full prescribing information#

Active ingredient(s):

OTC - ACTIVE INGREDIENT SECTION

Alcohol (ethanol) 65%.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s):

INDICATIONS & USAGE SECTION

Helps reduce bacteria that can potentially become disease.

WARNING

WARNINGS SECTION

For external use only. FLAMMABLE: Keep away from heat and flame.
Do NOT USE: On children less than 2 months of age.
Do NOT USE: On open skin wounds.
Keep out of eyes, ears, and mouth. Stop use if rash or irritation occurs. This could be a sign of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed contact doctor or poison control right away. 

Directions: 

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces, rub together until dry.
Supervise children under 6 years of age to prevent swallowing.

Other Information:

STORAGE AND HANDLING SECTION

Store between 59-86°F. DO NOT store in heat above 105°F. May discolor some fabrics. Harmful to wood surfaces and plastics. 

Inactive ingredient(s): 

INACTIVE INGREDIENT SECTION

Glycerin, Aloe Barbadensis Leaf Juice, Hydroxyethylcellulose, Purified Water, Essential Oils

SPL UNCLASSIFIED SECTION

One Drop GEL

Alcohol Antiseptic 65%/Topical Solution

Produced & Bottled By Four Fathers Distillery
2917 Borden St., Jacksonville, FL 32209

MADE IN USA

FOUR FATHERS Distillery, Jacksonville, Florida
For questions, concerns or help please call the distillery at 904-710-615

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DropgelDropgel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN2
902574ethanol 0.65 ML/ML Topical GelSCD2
902574ethyl alcohol 65 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78829-101-382022-01-28C16284748780-1d6a99b39-b1d7-a426-e053-dadaa90af4c2Insta-Shield Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78829-101-38Insta-ShieldHand Sanitizer Gel3785 mL in 1 JUGGEL37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78829-101INSTA-SHIELD HAND SANITIZER GEL (ALCOHOL) GEL [FOUR FATHERS DISTILLERY LLC]2Legacy NDC, 1 package rows20201009_f8d3cd6d-780b-4d8b-bd9e-0bd7ebc85ffd.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78829-10178829-101-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
c38067c0-e5c8-417a-b05b-06c84aa59f52f8d3cd6d-780b-4d8b-bd9e-0bd7ebc85ffd2020-10-08WarningsExact identifier
spl id: c38067c0-e5c8-417a-b05b-06c84aa59f52
spl set id: f8d3cd6d-780b-4d8b-bd9e-0bd7ebc85ffd

Reported adverse events (FAERS/openFDA)#

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