Hand Sanitizer

Manufacturer
Ultra Distributors Inc.
Effective date
2020-06-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:56

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Storage and handling

Other information do not store above 105°F may discolor some fabics harmful to wood finished and plastics

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Ethyl Alcohol 70%

OTC - PURPOSE SECTION

Purpose
Antiseptic

INDICATIONS & USAGE SECTION

Uses to decrease bacteria on the skin that could cause disease recommended for repeated use

WARNINGS SECTION

Warnings
for external use only: hands
Flammable. Keep away from fire or flame

OTC - WHEN USING SECTION

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin. do not inhale or ingest.

OTC - STOP USE SECTION

Stop use and ask a doctor if . irritation or redness develops. 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(1-800-222-1222)right away .

DOSAGE & ADMINISTRATION SECTION

Directions

  • wet hands thoroughly with product and allow to dry without wiping.
  • for children under 6 , use only under adult supervision.
  • not recommented for infants .

STORAGE AND HANDLING SECTION

Other information

  • do not store above 105°F
  • may discolor some fabics
  • harmful to wood finished and plastics

INACTIVE INGREDIENT SECTION

Inactive ingredients

acrylates/C10-C30 alkyl acrylate crosspolymer,aloe barbadensis leaf juice, aminomethyl propanol, glycerin, maltodextrin, propylene glycol, water , tocopheryl acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78495-008-012025-01-30C16284748780-12cef2736-7059-d83d-e063-dadaa90ab31fa72843fc-0efa-5fa0-e053-2a95a90a6416

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78495-008-01Hand Sanitizer236 mL in 1 BOTTLE, PUMPGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78495-008HAND SANITIZER (ETHYL ALCOHOL) GEL [ULTRA DISTRIBUTORS INC.]1Legacy NDC, 1 package rows20200604_a72843fc-0efa-5fa0-e053-2a95a90a6416.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78495-00878495-008-01

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
a72843fc-0efb-5fa0-e053-2a95a90a6416a72843fc-0efa-5fa0-e053-2a95a90a64162020-06-03WarningsExact identifier
spl id: a72843fc-0efb-5fa0-e053-2a95a90a6416
spl set id: a72843fc-0efa-5fa0-e053-2a95a90a6416

Reported adverse events (FAERS/openFDA)#

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