FDA.reportPublic FDA data

Antibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray

Manufacturer
Tropical Enterprises International, Inc.
Effective date
2017-02-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:49:56

Label at a glance#

ProductSkin Crave non-alcohol Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Uses : For hand sanitizing to decrease bacteria on the skin. Recommended for repeat use.

Dosage and administration

Directions : Pump or spray a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions: Pump or spray a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Water, 2-Phenoxyethanol

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Uses: For hand sanitizing to decrease bacteria on the skin. Recommended for repeat use.

OTC PURPOSE

OTC - PURPOSE SECTION

Purpose... Antimicrobial

WARNINGS

WARNINGS SECTION

WARNINGS For external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLPDLPLPDL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-786-002020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray
58418-786-012020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray
58418-786-022020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray
58418-786-042020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray
58418-786-052020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray
58418-786-082020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray
58418-786-102020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray
58418-786-122020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray
58418-786-162020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray
58418-786-172020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray
58418-786-282020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray
58418-786-642020-01-31C16284748780-19d75b9d0-2a04-f424-e053-dadaa90a57ceAntibacterial Non-Alcohol Hand Sanitizer Benzalkonium Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-786-00Skin Crave non-alcohol Hand Sanitizer10 mL in 1 PACKETSPRAY102
58418-786-01Skin Crave non-alcohol Hand Sanitizer30 mL in 1 BOTTLE, SPRAYSPRAY302
58418-786-02Skin Crave non-alcohol Hand Sanitizer60 mL in 1 BOTTLE, SPRAYSPRAY602
58418-786-04Skin Crave non-alcohol Hand Sanitizer120 mL in 1 BOTTLE, SPRAYSPRAY1202
58418-786-05Skin Crave non-alcohol Hand Sanitizer15 mL in 1 BOTTLE, SPRAYSPRAY152
58418-786-08Skin Crave non-alcohol Hand Sanitizer240 mL in 1 BOTTLE, SPRAYSPRAY2402
58418-786-10Skin Crave non-alcohol Hand Sanitizer10 mL in 1 BOTTLE, SPRAYSPRAY102
58418-786-12Skin Crave non-alcohol Hand Sanitizer360 mL in 1 BOTTLE, PUMPSPRAY3602
58418-786-16Skin Crave non-alcohol Hand Sanitizer480 mL in 1 BOTTLE, PUMPSPRAY4802
58418-786-17Skin Crave non-alcohol Hand Sanitizer50.275 mL in 1 BOTTLE, PUMPSPRAY50.2752
58418-786-28Skin Crave non-alcohol Hand Sanitizer3840 mL in 1 BOTTLE, PUMPSPRAY38402
58418-786-64Skin Crave non-alcohol Hand Sanitizer1920 mL in 1 BOTTLE, PUMPSPRAY19202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-786SKIN CRAVE NON-ALCOHOL HAND SANITIZER (ANTIBACTERIAL NON-ALCOHOL HAND SANITIZER) SPRAY [TROPICAL ENTERPRISES INTERNATIONAL, INC.]2Legacy NDC, 12 package rows20170525_2bb0c814-13e7-35c7-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58418-78658418-786-00, 58418-786-05, 58418-786-10, 58418-786-01, 58418-786-02, 58418-786-04, 58418-786-08, 58418-786-12, 58418-786-16, 58418-786-64, 58418-786-28, 58418-786-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOLY050HYR4XAIACT

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
48440f5b-7f26-224a-e054-00144ff8d46c2bb0c814-13e7-35c7-e054-00144ff8d46c2017-02-11WarningsExact identifier
spl id: 48440f5b-7f26-224a-e054-00144ff8d46c
spl set id: 2bb0c814-13e7-35c7-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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