FDA.reportPublic FDA data

Vitabath Hand Sanitizer Cool Spearmint and Thyme

Manufacturer
Vitabath Inc. | Canadian Custom Packaging Comapany
Effective date
2020-04-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:05:27

Label at a glance#

ProductVitabath Hand Sanitizer Cool Spearmint and Thyme
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

• Hand Sanitizer to help reduce bacteria on the skin • recommended for repeated use

Dosage and administration

Directions • Place enough product in your palm to thoroughtly spread on both hands and rub into the skin until dry • Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 63% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• Hand Sanitizer to help reduce bacteria on the skin • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only.
Flammable. Keep away from open flame and sources of heat.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if • 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..

Directions

DOSAGE & ADMINISTRATION SECTION

Directions • Place enough product in your palm to thoroughtly spread on both hands and rub into the skin until dry • Children under 6 years of age should be supervised when using this product.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other Information: • Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Ascorbic Acid, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Coffea Arabica (Coffee) Seed Extract, Eucalyptus Globulus Leaf Oil, Euterpe Oleracea Fruit Extract, Fragrance (Parfum), Garcinia Mangostana Fruit Extract, Glycerin, Lycium Barbarum Fruit Extract, Morinda Citrifolia Fruit Extract, Niacinamide, Panthenol, Punica Granatum Extract, Purified Water, Retinyl Palmitate, Tocopheryl Acetate.

OTC - QUESTIONS SECTION

Questions? Call toll-free 1-888-673-3377

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle Label Bottle LabelBottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094724ethanol 63 % Topical GelPSN2
1094724ethanol 0.63 ML/ML Topical GelSCD2
1094724ethanol 63 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73172-006-012023-01-30C16284748780-1f386c649-b9e7-0266-e053-dadaa90a7c1aVitabath Hand Sanitizer Cool Spearment and Thyme
73172-006-022023-01-30C16284748780-1f386c649-b9e7-0266-e053-dadaa90a7c1aVitabath Hand Sanitizer Cool Spearment and Thyme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73172-006-01Vitabath Hand Sanitizer Cool Spearmint and Thyme473 mL in 1 BOTTLEGEL4732
73172-006-02Vitabath Hand Sanitizer Cool Spearmint and Thyme976 mL in 1 BOTTLEGEL9762

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73172-006VITABATH HAND SANITIZER COOL SPEARMINT AND THYME (ALCOHOL) GEL [VITABATH INC.]2Legacy NDC, 2 package rows20200409_a1b3f167-eb50-5d55-e053-2a95a90a2a39.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73172-00673172-006-01, 73172-006-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOMER 1342809Y72KV36IACT
CHAMOMILEFGL3685T2XIACT
ARABICA COFFEE BEAN3SW678MX72IACT
ACAI46AM2VJ0AWIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
GARCINIA MANGOSTANA FRUIT832X5KK78YIACT
GLYCERINPDC6A3C0OXIACT
EUCALYPTUS OIL2R04ONI662IACT
LYCIUM BARBARUM FRUIT930626MWDLIACT
NONI FRUIT7829X3G2X5IACT
NIACINAMIDE25X51I8RD4IACT
PANTHENOLWV9CM0O67ZIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a2cb4e08-b5d1-0bd6-e053-2995a90a018ba1b3f167-eb50-5d55-e053-2a95a90a2a392020-04-08WarningsExact identifier
spl id: a2cb4e08-b5d1-0bd6-e053-2995a90a018b
spl set id: a1b3f167-eb50-5d55-e053-2a95a90a2a39

Reported adverse events (FAERS/openFDA)#

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