Hand Sanitizer

Manufacturer
Tropical Seas, Inc.
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:42:02

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

for sanitizing hands to help reduce bacteria on the skin. for deodorizing hands to help reduce odors on the skin.

Dosage and administration

rinse solids & slime from hands if possible. pat dry. put a thumbnail size amount in your palm and rub hands together briskly until dry. repeat as needed. children under 6 months: As a doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 64.325%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for sanitizing hands to help reduce bacteria on the skin.
  • for deodorizing hands to help reduce odors on the skin.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • rinse solids & slime from hands if possible.
  • pat dry.
  • put a thumbnail size amount in your palm and rub hands together briskly until dry.
  • repeat as needed.
  • children under 6 months: As a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

deionized water, glycerin, acrylates/c10-30 alkyl acrylate crosspolymer, aminomethyl propanol, and fragrance.

Other Information

SPL UNCLASSIFIED SECTION

Warning: Flammable

  • do not use near open flame or heat source
  • do not store above 110°F (43°C)
  • protect this product from excessive heat and direct sun
  • may discolor certain fabrics or surfaces

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free1-800-368-7327

Principal Display Panel - Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60ml NDC: 52854-600-01 60ml label60ml label

119ml NDC: 52854-600-02 119ml label119ml label

237ml NDC: 52854-600-03 237ml label237ml label

250ml NDC: 52854-600-04 250ml label250ml label

1000ml NDC: 52854-600-05 1000ml label1000ml label

3785ml NDC: 52854-600-06 3785ml label3785ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2468410ethanol 64.3 % Topical SolutionPSN6
2468410ethanol 0.643 ML/ML Topical SolutionSCD6
2468410ethanol 64.3 % Topical SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-600-01Hand Sanitizer60 mL in 1 BOTTLELIQUID606
52854-600-02Hand Sanitizer119 mL in 1 BOTTLELIQUID1196
52854-600-03Hand Sanitizer237 mL in 1 BOTTLE, PUMPLIQUID2376
52854-600-04Hand Sanitizer250 mL in 1 BOTTLELIQUID2506
52854-600-05Hand Sanitizer1000 mL in 1 BOTTLE, PUMPLIQUID10006
52854-600-06Hand Sanitizer3785 mL in 1 JUGLIQUID37856

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52854-60052854-600-01, 52854-600-02, 52854-600-03, 52854-600-04, 52854-600-05, 52854-600-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-01full-release2026-06-01 00:33:27

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
Hand SanitizerSDA 40B ALCOHOL 200 PROOFTropical Seas, Inc.b48f9afa-1634-e63e-e053-2a95a90a32bf2025-11-04WarningsExact identifier
ndc (package): 52854-600-02
ndc (package): 52854-600-06
ndc (package): 52854-600-03
ndc (package): 52854-600-04
ndc (package): 52854-600-01
ndc (package): 52854-600-05
ndc (product): 52854-600
ndc11 (package): 52854060002
ndc11 (package): 52854060003
ndc11 (package): 52854060004
ndc11 (package): 52854060006
ndc11 (package): 52854060005
ndc11 (package): 52854060001
spl id: 42c995c5-fd32-3792-e063-6294a90ae700
spl set id: b48f9afa-1634-e63e-e053-2a95a90a32bf

Reported adverse events (FAERS/openFDA)#

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