FDA.reportPublic FDA data

Alcohol

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:48:19

Label at a glance#

ProductAlcohol
Active ingredientALCOHOL
Label structure13 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only: hands

Flammable, keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes.  In case of contact with eyues, flush thoroughly with water.
  • avoid contact with broken skin
  • do not inhale of ingest

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

  • do not store above 105° F
  • may discolor some fabrics
  • harmful to wood finishes and plastic

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, carbomer, fragrance, glycerin, isopropyl myristate, Aloe barbadensis leaf juice, tocopheryl acetate, blue 1, yellow 5

Claim

SPL UNCLASSIFIED SECTION

*Effective at elimnating 99.99% of many common harmful germs and bacteria in as little as 15 seconds.

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY

OLD EAST MAIN CO,

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed! (888)309-9030

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STUDIO SELECTION ®

moisturizing

HAND SANITIZER with aloe

  • with Vitamin E
  • Kills 99.99% of many common germs & bacteria*

2 FL OZ (59 mL)

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247835ethanol 62 % Topical SolutionPSN12
247835ethanol 0.62 ML/ML Topical SolutionSCD12
247835ethanol 62 % Topical SolutionSY12
247835ethyl alcohol 62 % Topical SolutionSY12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-889-16Alcohol59 mL in 1 BOTTLE, PLASTICLIQUID5912
55910-889-48Alcohol1005 mL in 1 BOTTLE, PLASTICLIQUID100512

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-88955910-889-16, 55910-889-48

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOEV5VD430YW9IACT
TOCOPHEROLR0ZB2556P8IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ALCOHOL3K9958V90MACTIB

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
AlcoholALCOHOLOld East Main Co.31a38e0e-41de-4638-9e86-df1923b64d522026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 55910-889-16
ndc (package): 55910-889-48
ndc (product): 55910-889
ndc11 (package): 55910088948
ndc11 (package): 55910088916
spl id: 4c102ec4-1ff3-dca3-e063-6294a90afe86
spl set id: 31a38e0e-41de-4638-9e86-df1923b64d52

Reported adverse events (FAERS/openFDA)#

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