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FDA Approval

Alcohol Prep Pads

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Family Dollar Stores, Inc.
DUNS: 024472631
Effective Date
April 18, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Isopropyl alcohol(70 mL in 100 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Medline Industries, LP

025460908

Products1

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

Alcohol Prep Pads

Product Details

NDC Product Code
55319-821
Application Number
M003
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
April 18, 2025
Code: ND2M416302Class: ACTIBQuantity: 70 mL in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION


WARNINGS SECTION


OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION


SPL UNCLASSIFIED SECTION

OTHER SAFETY INFORMATION

INACTIVE INGREDIENT SECTION


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