Coola Bare Hands Hand Sanitizer Spray

Manufacturer
Bell International Labroatories, Inc.
Effective date
2020-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:13:36

Label at a glance#

ProductBare Hands
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

to help reduce bacteria on the skin. recommended for repeated use

Dosage and administration

Dispense an adequate amount in your hands and rub hands together until dry. Does not require rinising.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

to help reduce bacteria on the skin.

recommended for repeated use

RECENT MAJOR CHANGES SECTION

There was no changes. I was just reviewing the content.

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from fire/flame.

When using this product do not use in or near the eyes. In case of eye contact, rinse thoroughly with water.

Stop use and ask a dotor if irritaion or rash appears and lasts.

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. Children under 6 years of age should be supervised.

Directions

DOSAGE & ADMINISTRATION SECTION

Dispense an adequate amount in your hands and rub hands together until dry. Does not require rinising.

Other information

OTHER SAFETY INFORMATION

Do not store above 104 F (40 C). May discolor certain fabrics or surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Water

3.4 fl oz bottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.4 fl oz bottle label3.4 fl oz bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020364ethanol 62 % Topical SprayPSN1
1020364ethanol 0.62 ML/ML Topical SpraySCD1
1020364ethanol 62 % Topical SpraySY1
1020364ethyl alcohol 62 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76150-239-042023-01-30C16284748780-1f386c649-b566-0266-e053-dadaa90a7c1aCoola Bare Hands Hand Sanitizer Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76150-239-04Bare Hands100 mL in 1 BOTTLESPRAY1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76150-239BARE HANDS (HAND SANITIZER) SPRAY [BELL INTERNATIONAL LABROATORIES, INC.]1Legacy NDC, 1 package rows20200519_a5ecbf25-ebb7-6905-e053-2995a90aef23.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
76150-23976150-239-04

Ingredients#

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

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

Source Document#

Source XML · Source PDF

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
a5ecbf25-ebb8-6905-e053-2995a90aef23a5ecbf25-ebb7-6905-e053-2995a90aef232020-05-18WarningsExact identifier
spl id: a5ecbf25-ebb8-6905-e053-2995a90aef23
spl set id: a5ecbf25-ebb7-6905-e053-2995a90aef23

Reported adverse events (FAERS/openFDA)#

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