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Equaline Redness Relief Lubricant Eye Drops

Equaline Redness Relief Lubricant Eye Drops15mL (PLD)

Approved
Approval ID

31a30b00-9f4b-717a-e063-6394a90a8a87

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jan 1, 2024

Manufacturers
FDA

United Natural Foods, Inc

DUNS: 943556183

Products 1

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

Glycerin, Naphazoline hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83455-213
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Glycerin, Naphazoline hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 1, 2024
FDA Product Classification

INGREDIENTS (7)

BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
GLYCERINActive
Quantity: 0.25 g in 100 mL
Code: PDC6A3C0OX
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NAPHAZOLINE HYDROCHLORIDEActive
Quantity: 0.012 g in 100 mL
Code: MZ1131787D
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT

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Equaline Redness Relief Lubricant Eye Drops - FDA Drug Approval Details