Foaming Instant Hand Sanitizer with Aloe and Vitamin E

Manufacturer
Kutol Products Company, Inc.
Effective date
2019-01-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:58:13

Label at a glance#

ProductFoaming Instant Hand Sanitizer with Aloe and Vitamin E
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w.....Antibacterial Agent

INACTIVE INGREDIENT SECTION

Water, Fragrance, Aloe Barbadensis Leaf, Tocopheryl Acetate, Cocamidopropyl Betaine, Propylene Glycol, Phenoxyethanol, PEG-7 Glyceryl Cocoate, Tetrasodium EDTA.

OTC - PURPOSE SECTION

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

WARNINGS SECTION

For external use only.

Avoid contact with eyes. If contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

DOSAGE & ADMINISTRATION SECTION

To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Avoid contact with eyes. If contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact a physician or poison control center.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Foaming Instant 1000 mLFoaming Instant 1000 mL532 mL532 mLFoaming Instant 1250 mLFoaming Instant 1250 mLFoaming Instant 3.785 LFoaming Instant 3.785 LFoaming Instant 950 mLFoaming Instant 950 mLFoaming Instant 532 mLFoaming Instant 532 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN3
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD3
1049254benzalkonium chloride 0.13 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-207-03Foaming Instant Hand Sanitizer with Aloe and Vitamin E208175 mL in 1 DRUMSOLUTION2081753
50865-207-09Foaming Instant Hand Sanitizer with Aloe and Vitamin E3785 mL in 1 BOTTLE, PLASTICSOLUTION37853
50865-207-17Foaming Instant Hand Sanitizer with Aloe and Vitamin E50 mL in 1 BOTTLE, PLASTICSOLUTION503
50865-207-24Foaming Instant Hand Sanitizer with Aloe and Vitamin E1000 mL in 1 BAGSOLUTION10003
50865-207-31Foaming Instant Hand Sanitizer with Aloe and Vitamin E1000 mL in 1 BAGSOLUTION10003
50865-207-41Foaming Instant Hand Sanitizer with Aloe and Vitamin E1000 mL in 1 BAGSOLUTION10003
50865-207-78Foaming Instant Hand Sanitizer with Aloe and Vitamin E950 mL in 1 BOTTLE, PLASTICSOLUTION9503
50865-207-91Foaming Instant Hand Sanitizer with Aloe and Vitamin E532 mL in 1 BOTTLE, PLASTICSOLUTION5323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-207FOAMING INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E SOLUTION [KUTOL PRODUCTS COMPANY, INC.]3Legacy NDC, 8 package rows20190117_3429c36b-47af-5ff9-e054-00144ff88e88.zip

Products#

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NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
7f98884b-0337-c15e-e053-2a91aa0acef03429c36b-47af-5ff9-e054-00144ff88e882019-01-16WarningsExact identifier
spl id: 7f98884b-0337-c15e-e053-2a91aa0acef0
spl set id: 3429c36b-47af-5ff9-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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