FDA Product

RELEGARD

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

RELEGARD

FDA Product Code

51674-0130

Regulatory Information

NDC Product Code

51674-0130

Effective Date

March 20, 2017

FDA Title

RELEGARD THERAPEUTIC VAGINAL GEL WITH APPLICATOR

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerBLANSETT PHARMACAL CO

DUNS Number

037477378

Active Ingredients

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

LACTIC ACID

Code: 33X04XA5AT

Class Code: IACT

POLYETHYLENE GLYCOL 4500

Code: TVH7653921

Class Code: IACT

Quantity: 0.9 mg in 1 mL

Code: Q40Q9N063P

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

Quantity: 0.025 mg in 1 mL

Code: 5UTX5635HP

Class Code: ACTIB

Active Moieties

ACETIC ACID

Code: Q40Q9N063P

OXYQUINOLINE

Code: 5UTX5635HP

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