MedPath

Alcohol Prep Pads

55319-821 Family Dollar IPA Prep Pad

Approved
Approval ID

15af30ec-f77d-2f5c-e063-6394a90a0580

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 18, 2025

Manufacturers
FDA

Family Dollar Stores, Inc.

DUNS: 024472631

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

isopropyl alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55319-821
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
isopropyl alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 18, 2025
FDA Product Classification

INGREDIENTS (2)

ISOPROPYL ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: ND2M416302
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2024

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2024

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2024

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2024

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2024

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2024

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/1/2024

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2024

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/1/2024

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Alcohol Prep Pads - FDA Drug Approval Details