Coola Bare Hands Hand Sanitizer Gel

Manufacturer
Bell International Laboratories, 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 structure7 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 rinsing.

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

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from fire/flame.

Do not use product in/near the eyes. In case of eye contact, rinse thoroughly with water.

Stop use and ask a doctor if irritation 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 age 6 should be supervised.

Directions

DOSAGE & ADMINISTRATION SECTION

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

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, Citric Acid, Glycerin, Hydroxypropyl Guar, Water

1.8 fl oz bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1.8 fl oz bottle1.8 fl oz bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76150-240-052023-01-30C16284748780-1f386c649-fe63-0266-e053-dadaa90a7c1aCoola Bare Hands Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76150-240-05Bare Hands53 mL in 1 BOTTLEGEL531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76150-240BARE HANDS (HAND SANITIZER) GEL [BELL INTERNATIONAL LABORATORIES, INC.]1Legacy NDC, 1 package rows20200519_a5ed2e88-2ecf-ddfd-e053-2995a90af914.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76150-24076150-240-05

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 · 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
a5ed2e88-2ed0-ddfd-e053-2995a90af914a5ed2e88-2ecf-ddfd-e053-2995a90af9142020-05-18WarningsExact identifier
spl id: a5ed2e88-2ed0-ddfd-e053-2995a90af914
spl set id: a5ed2e88-2ecf-ddfd-e053-2995a90af914

Reported adverse events (FAERS/openFDA)#

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