MedPath

Droptics Performance Eye Drops

Approved
Approval ID

20fd6822-a7fd-4593-92bb-0a07260893e2

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Mar 24, 2025

Manufacturers
FDA

Droptics LLC

DUNS: 119445348

Products 1

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

Naphazoline Hydrochloride, Propylene Glycol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85211-001
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Naphazoline Hydrochloride, Propylene Glycol
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 24, 2025
FDA Product Classification

INGREDIENTS (11)

BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
BORNEOLInactive
Code: M89NIB437X
Classification: IACT
CAFFEINEInactive
Code: 3G6A5W338E
Classification: IACT
TAURINEInactive
Code: 1EQV5MLY3D
Classification: IACT
NAPHAZOLINE HYDROCHLORIDEActive
Quantity: 0.03 g in 100 mL
Code: MZ1131787D
Classification: ACTIB
PROPYLENE GLYCOLActive
Quantity: 1 g in 100 mL
Code: 6DC9Q167V3
Classification: ACTIB
CAMPHOR (SYNTHETIC)Inactive
Code: 5TJD82A1ET
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
POTASSIUM ASPARTATEInactive
Code: OC4598NZEQ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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