FDA.reportPublic FDA data

Prima Clean Hands Moisturizing Hand Sanitizer Spray

Manufacturer
Bell International Laboratories, Inc
Effective date
2022-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:12

Label at a glance#

ProductPrima Clean Hands Moisturizing Hand SanitizerSpray
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Helps reduce bacteria on the skin Recommended for repeated use

Dosage and administration

Spray directly on all surfaces on hands and rub until dry For children under 6, use adult supervision Not recommended for infants

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Helps reduce bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable, keep away from fire, sparks, and sources of ignition.
    • When using this product:
    • Keep out of eyes
    • In case of contact with eyes, flush thoroughly with water
    • Avoid contact with broken skin
    • Stop use and ask doctor if irritation and redness develop and persist for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach with children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray directly on all surfaces on hands and rub until dry
  • For children under 6, use adult supervision
  • Not recommended for infants

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice

Cannabis Sativa (Hemp) Flower/Leaf/Stem Extract

Ceramide NG

Chenopodium Quinoa Seed Extract

Citrullus Lanatus (Watermelon) Fruit Extract

Eucalyptus Globulus Leaf Oil

Glycerin

Lavandula Angustifolia (Lavender) Oil

Mentha Piperita (Peppermint) Oil

Olea Europaea (Olive) Fruit Oil

Ricinus Communis (Castor) Seed Oil

Sodium Lactate

Sodium PCA

Sucrose

Urea

Water

Other

OTHER SAFETY INFORMATION

Do not store above 104°/ 40°C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Made in the United States with thoughtfully sourced global materials

Formulated, Quality Tested and Distributed by The Uplifters' Prima, PBC (a Public Benefit Corp.)

Sanata Monica, CA 90401 | Prima Support: prima.co.hi

Adverse Health Events: 855-774-6226

prima.co © 2020 The Uplifters' Prima, 11PBC

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76150-355-762024-01-30C16284748780-11030e365-3100-111a-e063-dadaa90a10e2Prima Clean Hands Moisturizing Hand Sanitizer Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76150-355-76Prima Clean Hands Moisturizing Hand SanitizerSpray60 mL in 1 BOTTLE, GLASSSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76150-355PRIMA CLEAN HANDS MOISTURIZING HAND SANITIZERSPRAY (ETHYL ALCOHOL) SPRAY [BELL INTERNATIONAL LABORATORIES, INC]1Legacy NDC, 1 package rows20220414_dc8e4e95-8b27-5ef3-e053-2995a90aecc1.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
76150-35576150-355-76

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
ALCOHOL3K9958V90MACTIB
CERAMIDE NGC04977SRJ5IACT
WATERMELON231473QB6RIACT
CHENOPODIUM QUINOA SEEDOO4K72NZ2XIACT
ALOE VERA LEAFZY81Z83H0XIACT
SUCROSEC151H8M554IACT
SODIUM LACTATETU7HW0W0QTIACT
HEMPTD1MUT01Q7IACT
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
PEPPERMINT OILAV092KU4JHIACT
OLIVE OIL6UYK2W1W1EIACT
CASTOR OILD5340Y2I9GIACT
UREA8W8T17847WIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
dc8e4e95-8b28-5ef3-e053-2995a90aecc1dc8e4e95-8b27-5ef3-e053-2995a90aecc12022-04-13WarningsExact identifier
spl id: dc8e4e95-8b28-5ef3-e053-2995a90aecc1
spl set id: dc8e4e95-8b27-5ef3-e053-2995a90aecc1

Reported adverse events (FAERS/openFDA)#

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