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FDA Approval

Isopropyl Alcohol

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

FDA Approval Summary

Company
Effective Date
April 8, 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.

Consumer Product Partners, LLC

119091520

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Consumer Product Partners, LLC

Consumer Product Partners, LLC

Consumer Product Partners, LLC

119091514

Products1

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

Isopropyl Alcohol

Product Details

NDC Product Code
11344-810
Application Number
M003
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
April 8, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: ND2M416302Class: ACTIBQuantity: 70 mL in 100 mL
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