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FDA Approval

Me-Ga Care

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

FDA Approval Summary

Company
Effective Date
May 8, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Ethanol(55 mL in 100 mL)
Isopropyl alcohol(17 mL in 100 mL)

Manufacturing Establishments1

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

Babikian Healthcare Products CJSC

Babikian Healthcare Products CJSC

933894844

Products1

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

Me-Ga Care TM

Product Details

NDC Product Code
83640-272
Application Number
505G(a)(3)
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
May 8, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
EthanolActive
Code: 3K9958V90MClass: ACTIBQuantity: 55 mL in 100 mL
Code: ND2M416302Class: ACTIBQuantity: 17 mL in 100 mL
HYDROGEN PEROXIDEInactive
Code: BBX060AN9VClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
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