FDA.reportPublic FDA data

Bare Republic Bare Hands Hand Sanitizer Spray 3.4oz - Vanilla Coco

Manufacturer
COOLA LLC
Effective date
2020-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:03

Label at a glance#

ProductBare Republic Bare Hands Vanilla Coco
Active ingredientALCOHOL
Label structure9 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

Ehtyl 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.

Do not use on damaged or broken skin

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 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 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 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

Allyl Heptonate, Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Daucus Carota Sativa (Carrot) Root Extract, Gamma-Decalactone, Gamma-Nonalactone, Gamma Octalactone, Glycerin, Heliotropine, Pyrus Malus (Apple) Fruit Extract, Raspberry Ketone, Rubus Idaeus (Raspberry) Fruit Extract, Triethyl Citrate, Vanillin, Vitis Vinifera (Grape) Seed Oil, Water

Questions or comments?

OTC - QUESTIONS SECTION

Call 760-940-2125

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ArtworkArtwork

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
79753-005-012023-01-30C16284748780-1f386c649-b821-0266-e053-dadaa90a7c1aBare Republic Bare Hands Hand Sanitizer Spray 3.4oz - Vanilla Coco

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-005-01Bare Republic Bare HandsVanilla Coco100 mL in 1 BOTTLE, PUMPSPRAY1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-005BARE REPUBLIC BARE HANDS VANILLA COCO (HAND SANITIZER) SPRAY [COOLA LLC]1Legacy NDC, 1 package rows20201121_b4901def-ccf8-db77-e053-2a95a90a1bed.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-00579753-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
.GAMMA.-NONALACTONEI1XGH66S8PIACT
ALLYL HEPTANOATEAU4CYG9V68IACT
.GAMMA.-DECALACTONE7HLS05KP9OIACT
.GAMMA.-OCTALACTONEUHD6M52X0KIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
PIPERONALKE109YAK00IACT
GRAPE SEED OIL930MLC8XGGIACT
WATER059QF0KO0RIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
4-(P-HYDROXYPHENYL)-2-BUTANONE7QY1MH15BGIACT
VANILLINCHI530446XIACT
CARROTL56Z1JK48BIACT
APPLEB423VGH5S9IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALOE VERA LEAFZY81Z83H0XIACT
RASPBERRY4N14V5R27WIACT

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
b4901def-ccf9-db77-e053-2a95a90a1bedb4901def-ccf8-db77-e053-2a95a90a1bed2020-11-20WarningsExact identifier
spl id: b4901def-ccf9-db77-e053-2a95a90a1bed
spl set id: b4901def-ccf8-db77-e053-2a95a90a1bed

Reported adverse events (FAERS/openFDA)#

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