FDA.reportPublic FDA data

First Line Alcohol Wipes

Manufacturer
PayDirt Gold Company, LLC
Effective date
2020-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:33

Label at a glance#

ProductFirst Line Alcohol Wipes
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry. Children under 6 years of age should be supervised.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • Topical antiseptic
  • Recommended for repeated use

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months in age
  • on open skin wounds

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or redness develops and lasts more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry.
  • Children under 6 years of age should be supervised.

Other information

SPL UNCLASSIFIED SECTION

  • Store between 15°-30°C (59°-86°F)
  • Avoid freezing and excessive heat over 40°C (104°F)
  • Protect from direct sunlight. Keep container sealed.
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
81043-001-012022-01-28C16284748780-1d6a99b39-98d1-a426-e053-dadaa90af4c2First Line Alcohol Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81043-001-01First Line Alcohol Wipes3.8 mL in 1 PATCHCLOTH3.81
81043-001-01First Line Alcohol Wipes70 in 1 CANISTERCLOTH701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81043-001FIRST LINE ALCOHOL WIPES (ALCOHOL) CLOTH [PAYDIRT GOLD COMPANY, LLC]1Legacy NDC, 2 package rows20201113_b3eddf05-d339-faac-e053-2a95a90a81d5.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
81043-00181043-001-01

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
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
b3ee1be6-1724-0890-e053-2995a90a0c6ab3eddf05-d339-faac-e053-2a95a90a81d52020-11-12WarningsExact identifier
spl id: b3ee1be6-1724-0890-e053-2995a90a0c6a
spl set id: b3eddf05-d339-faac-e053-2a95a90a81d5

Reported adverse events (FAERS/openFDA)#

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