FDA.reportPublic FDA data

Mentholatum Moisturizing Hand Sanitizer

Manufacturer
The Mentholatum Company
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:43:07

Label at a glance#

ProductMentholatum Moisturizing Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

Hand sanitizer to reduce bacteria on the skin

Dosage and administration

Liberally apply product in your palm to thoroughly cover your hands Rub hands together briskly until absorbed. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Skin antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer to reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation or rash appears and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Liberally apply product in your palm to thoroughly cover your hands
  • Rub hands together briskly until absorbed.
  • Children under 6 years of age should be supervised when using this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, hydroxypropyl starch phosphate, lauryl glucoside, dimethicone, chlorphenesin, edetate disodium, glycerin, hyaluronic acid, methyl gluceth-20, phenoxyethanol, polyquaternium-7, rosmarinus officinalis (rosemary) leaf oil, silanetriol

Questions?

OTC - QUESTIONS SECTION

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mentholatum Moisturizing Hand Sanitizer
Mentholatum Moisturizing Hand Sanitizer

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098199benzalkonium chloride 0.13 % Topical GelPSN4
1098199benzalkonium chloride 0.0013 MG/MG Topical GelSCD4
1098199benzalkonium chloride 0.13 % Topical GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-0004-1Mentholatum Moisturizing Hand Sanitizer192 mL in 1 BOTTLEGEL1924

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-0004MENTHOLATUM MOISTURIZING HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 1 package rows20241215_365c93bc-2299-4e69-ba3a-69414bfe78d7.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-000410742-0004-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN9F8ET54T05IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
DIMETHICONE92RU3N3Y1OIACT
CHLORPHENESINI670DAL4SZIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
HYALURONIC ACIDS270N0TRQYIACT
METHYL GLUCETH-20J3QD0LD11PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
ROSEMARY OIL8LGU7VM393IACT
SILANETRIOLE52D0J3TS5IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
Mentholatum Moisturizing Hand SanitizerBENZALKONIUM CHLORIDEThe Mentholatum Company365c93bc-2299-4e69-ba3a-69414bfe78d72024-12-13WarningsExact identifier
ndc (package): 10742-0004-1
ndc (product): 10742-0004
ndc11 (package): 10742000401
spl id: 292b8cf3-73cf-8681-e063-6394a90abb04
spl set id: 365c93bc-2299-4e69-ba3a-69414bfe78d7

Reported adverse events (FAERS/openFDA)#

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