FDA.reportPublic FDA data

Promedic

Manufacturer
Perfect Medics, Inc
Effective date
2020-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:21

Label at a glance#

ProductPromedic
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

to decrease bacteria on the skin that could cause disease.

Dosage and administration

Wipe down surface thoroughly and allow to air-dry. For children under 6, use only under adult supervision. Not recommended for infants.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Warnings

WARNINGS SECTION

For external use only - hands

Flammable, keep away from heat and flame.

When using the 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.

Stop use and ask a doctor if skin irritation develops

Uses

INDICATIONS & USAGE SECTION

  • to decrease bacteria on the skin that could cause disease.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wipe down surface thoroughly and allow to air-dry.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.

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.

Other Information

SPL UNCLASSIFIED SECTION

  • do not store above 105F

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Benzethonium chloride.

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN1
1307051ethanol 0.75 ML/ML Medicated PadSCD1
1307051ethanol 75 % Hand Sanitizer WipesSY1
1307051ethyl alcohol 75 % Topical ClothSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79134-002-012022-01-28C16284748780-1d6a99b39-aa1e-a426-e053-dadaa90af4c2Promedic DISINFECTING WIPES
79134-002-022022-01-28C16284748780-1d6a99b39-aa1e-a426-e053-dadaa90af4c2Promedic DISINFECTING WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79134-002-01Promedic432 g in 1 PACKETCLOTH4321
79134-002-02Promedic448 g in 1 PACKETCLOTH4481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79134-002PROMEDIC (ALCOHOL) CLOTH [PERFECT MEDICS, INC]1Legacy NDC, 2 package rows20200628_f73d976a-626a-4d88-884a-088146d87fa9.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79134-00279134-002-01, 79134-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
BENZETHONIUM CHLORIDEPH41D05744IACT

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
a5082689-f57f-47e7-aa0a-126cf1852964f73d976a-626a-4d88-884a-088146d87fa92020-06-18WarningsExact identifier
spl id: a5082689-f57f-47e7-aa0a-126cf1852964
spl set id: f73d976a-626a-4d88-884a-088146d87fa9

Reported adverse events (FAERS/openFDA)#

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