FDA.reportPublic FDA data

PREMIUM HAND SANITIZER

Manufacturer
MD Science Lab LLC
Effective date
2020-04-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:08:44

Label at a glance#

ProductPREMIUM HAND SANITIZER
Active ingredientBenzalkonium Chloride
Label structure8 sections

Dosage and administration

Pump a small amount of liquid into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

  • For external use only.

OTC - WHEN USING SECTION

  • When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

OTC - STOP USE SECTION

  • Stop use and a ask doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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

  • Pump a small amount of liquid into palm of hand.
  • Rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly until dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), Propylene Glycol, Polysorbate 20, Phenoxyethanol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Aloe barbadensis (Aloe Vera).

PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

M.D.
Science Lab
LLC

PREMIUM
hand
sanitizer
with Tea Tree Oil & Aloe

Kills 99.99% of Germs

Antimicrobial - Alcohol Free

moisturizes & softens skin

8 fl oz 237ml e

PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN2
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD2
1049254benzalkonium chloride 0.13 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69898-501-012022-01-28C16284748780-1d6a99b39-a4a7-a426-e053-dadaa90af4c2PREMIUM HAND SANITIZER
69898-501-072022-01-28C16284748780-1d6a99b39-a4a7-a426-e053-dadaa90af4c2PREMIUM HAND SANITIZER
69898-501-082022-01-28C16284748780-1d6a99b39-a4a7-a426-e053-dadaa90af4c2PREMIUM HAND SANITIZER
69898-501-122022-01-28C16284748780-1d6a99b39-a4a7-a426-e053-dadaa90af4c2PREMIUM HAND SANITIZER
69898-501-322022-01-28C16284748780-1d6a99b39-a4a7-a426-e053-dadaa90af4c2PREMIUM HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69898-501-01PREMIUM HAND SANITIZER3785 mL in 1 BOTTLE, PLASTICLIQUID37852
69898-501-07PREMIUM HAND SANITIZER221 mL in 1 BOTTLE, PLASTICLIQUID2212
69898-501-08PREMIUM HAND SANITIZER236 mL in 1 BOTTLE, PLASTICLIQUID2362
69898-501-12PREMIUM HAND SANITIZER354 mL in 1 BOTTLE, PLASTICLIQUID3542
69898-501-32PREMIUM HAND SANITIZER946 mL in 1 BOTTLE, PLASTICLIQUID9462

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69898-501PREMIUM HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [MD SCIENCE LAB LLC]2Legacy NDC, 5 package rows20200430_002affb4-0499-4c16-bd7f-cff06e9d4e8b.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69898-50169898-501-08, 69898-501-12, 69898-501-32, 69898-501-01, 69898-501-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzalkonium ChlorideF5UM2KM3W7ACTIB
Water059QF0KO0RIACT
Propylene Glycol6DC9Q167V3IACT
PhenoxyethanolHIE492ZZ3TIACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
ALOE VERA LEAFZY81Z83H0XIACT
Polysorbate 207T1F30V5YHIACT

Source Document#

Source XML · Source PDF

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
9e774ccd-eabf-4f7e-bbe6-aa5a21226130002affb4-0499-4c16-bd7f-cff06e9d4e8b2020-04-29WarningsExact identifier
spl id: 9e774ccd-eabf-4f7e-bbe6-aa5a21226130
spl set id: 002affb4-0499-4c16-bd7f-cff06e9d4e8b

Reported adverse events (FAERS/openFDA)#

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