FDA.reportPublic FDA data

Silver Bear Distillery Hand Sanitizer

Manufacturer
Siver Bear Distillery | Silver Bear Distillery
Effective date
2020-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:21

Label at a glance#

ProductSilver Bear Distillery Hand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Label contents#

Full prescribing information#

Active Ingredient & back label

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient(s)

Alcohol 80%v/v.....Antiseptic

Back LabelBack Label

Use(s) Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap aand water are not availeble

OTC - PURPOSE SECTION

Use(s)
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap aand water
are not availeble

;kefewfk;kefewfk

Warnings

WARNINGS SECTION

Warnings

For external use only. Flammable. Keep away from heat or flame.

WarningsWarnings

Do not use • In children less than 2 months of age ​• On open skin wounds

OTC - DO NOT USE SECTION

Do not useDo not use

When Using this product keep out of eyes, ears an mouth. In case of contact with eyes, rinse eyes thouroghly with water.

OTC - WHEN USING SECTION

When usingWhen using

OTC - ASK DOCTOR SECTION

Stop Use and and ask a doctor if irritation or rash occurs.These may be signs of a serious condition

Stop useStop use

Keep Out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Keep out of reachKeep out of reach

INSTRUCTIONS FOR USE SECTION

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Instructions for useInstructions for use

OTHER SAFETY INFORMATION

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

other safety informationother safety information

INACTIVE INGREDIENT SECTION

Inactive ingredients Glycerin, hydrogen peroxide, purified water

Inactive ingredientsInactive ingredients

DOSAGE & ADMINISTRATION SECTION

TOPICAL SOLUTION

topical solutiontopical solution

WARNINGS SECTION

For external use only

Not safe for consumption

WarningWarning

INDICATIONS & USAGE SECTION

TOPICAL SOLUTION hAND SANITIZER

For external use only

Indications and usageIndications and usage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL ANTICEPTIC 80%

TOPICAL SOLUTION HAND SANITIZER

Silver Bear Distillery

For external use only

Not safe for consumption

473ml 16oz Non-sterile Solution

NDC74018-0001-1

front labelfront label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

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
74018-0001-12022-01-28C16284748780-1d6a99b39-d575-a426-e053-dadaa90af4c2a1c7efc3-1c07-827e-e053-2995a90ad0d1
74018-0001-22022-01-28C16284748780-1d6a99b39-d575-a426-e053-dadaa90af4c2a1c7efc3-1c07-827e-e053-2995a90ad0d1
74018-0001-32022-01-28C16284748780-1d6a99b39-d575-a426-e053-dadaa90af4c2a1c7efc3-1c07-827e-e053-2995a90ad0d1
74018-0001-42022-01-28C16284748780-1d6a99b39-d575-a426-e053-dadaa90af4c2a1c7efc3-1c07-827e-e053-2995a90ad0d1
74018-0001-52022-01-28C16284748780-1d6a99b39-d575-a426-e053-dadaa90af4c2a1c7efc3-1c07-827e-e053-2995a90ad0d1
74018-0001-62022-01-28C16284748780-1d6a99b39-d575-a426-e053-dadaa90af4c2a1c7efc3-1c07-827e-e053-2995a90ad0d1
74018-0001-72022-01-28C16284748780-1d6a99b39-d575-a426-e053-dadaa90af4c2a1c7efc3-1c07-827e-e053-2995a90ad0d1
74018-0001-82022-01-28C16284748780-1d6a99b39-d575-a426-e053-dadaa90af4c2a1c7efc3-1c07-827e-e053-2995a90ad0d1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74018-0001-1Silver Bear Distillery Hand Sanitizer473 mL in 1 BOTTLE, PLASTICLIQUID4731
74018-0001-2Silver Bear Distillery Hand Sanitizer355 mL in 1 BOTTLE, PUMPLIQUID3551
74018-0001-3Silver Bear Distillery Hand Sanitizer473 mL in 1 BOTTLE, PUMPLIQUID4731
74018-0001-4Silver Bear Distillery Hand Sanitizer355 mL in 1 BOTTLE, PLASTICLIQUID3551
74018-0001-5Silver Bear Distillery Hand Sanitizer375 mL in 1 BOTTLE, GLASSLIQUID3751
74018-0001-6Silver Bear Distillery Hand Sanitizer750 mL in 1 BOTTLE, GLASSLIQUID7501
74018-0001-7Silver Bear Distillery Hand Sanitizer237 mL in 1 BOTTLE, PLASTICLIQUID2371
74018-0001-8Silver Bear Distillery Hand Sanitizer946 mL in 1 BOTTLE, PLASTICLIQUID9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74018-0001SILVER BEAR DISTILLERY HAND SANITIZER LIQUID [SIVER BEAR DISTILLERY]1Legacy NDC, 8 package rows20200331_a1c7efc3-1c07-827e-e053-2995a90ad0d1.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74018-000174018-0001-1, 74018-0001-2, 74018-0001-3, 74018-0001-4, 74018-0001-5, 74018-0001-6, 74018-0001-7, 74018-0001-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCEROL FORMAL3L7GR2604EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
HYDROGEN PEROXIDEBBX060AN9VIACT

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
a1c7efc3-1c08-827e-e053-2995a90ad0d1a1c7efc3-1c07-827e-e053-2995a90ad0d12020-03-26WarningsExact identifier
spl id: a1c7efc3-1c08-827e-e053-2995a90ad0d1
spl set id: a1c7efc3-1c07-827e-e053-2995a90ad0d1

Reported adverse events (FAERS/openFDA)#

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