Acetic Acid
Acetic Acid Otic Solution, USP
Approved
Approval ID
7470a1ed-bc00-cb52-e053-2a91aa0a5c7d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-1739
Application NumberNDA012179
Product Classification
M
Marketing Category
C73594
G
Generic Name
Acetic Acid
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateFebruary 22, 2021
FDA Product Classification
INGREDIENTS (5)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLENE GLYCOL DIACETATEInactive
Code: 5Z492UNF9O
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
BENZETHONIUM CHLORIDEInactive
Code: PH41D05744
Classification: IACT
ACETIC ACIDActive
Quantity: 20.65 mg in 1 mL
Code: Q40Q9N063P
Classification: ACTIB