RELEGARD- glacial acetic acid, oxyquinoline gel

RELEGARD by

Drug Labeling and Warnings

RELEGARD by is a Prescription medication manufactured, distributed, or labeled by BLANSETT PHARMACAL CO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE AND ADMINISTRATION

TO OPEN: USE TOP OF CAP TO TWIST OFF SEAL.

FOR VAGINAL USE ONLY.

SPL UNCLASSIFIED SECTION

CONTAINS: GLACIAL ACETIC ACID 0.9%, OXYQUINOLINE 0.025%, PRESERVATIVE, GLYCERIN, LACTIC ACID BUFFER, POLYETHYLENE GLYCOL 4500 AND PURIFIED WATER. THE PH OF 3.8 - 4.3 IS ADJUSTED USING 1N POTASSIUM HYDROXIDE.

SPL UNCLASSIFIED SECTION

DO NOT USE IF TAMPER-RESISTANT SEAL AT OPENING HAS BEEN DISTURBED OR IS NOT VISIBLE. IF THIS SEAL HAS BEEN PUNCTURED OR IS NOT VISIBLE, RETURN PRODUCT TO PLACE OF PURCHASE.

SPL UNCLASSIFIED SECTION

STORE AT ROOM TEMPERATURE.

SPL UNCLASSIFIED SECTION

DO NOT TAKE BY MOUTH OR USE IN EYES.

SPL UNCLASSIFIED SECTION

COMPLETE PRESCRIBING INFORMATION IS ENCLOSED.

THIS BOX CONTAINS ONE APPLICATOR.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RELEGARD 
glacial acetic acid, oxyquinoline gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51674-0130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)	ACETIC ACID	0.9 mg  in 1 mL
OXYQUINOLINE (UNII: 5UTX5635HP) (OXYQUINOLINE - UNII:5UTX5635HP)	OXYQUINOLINE	0.025 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)
WATER (UNII: 059QF0KO0R)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51674-0130-5	50 mL in 1 TUBE; Type 0: Not a Combination Product	03/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/20/2017

Labeler - BLANSETT PHARMACAL CO (037477378)

Establishment
Name	Address	ID/FEI	Business Operations
BLANSETT PHARMACAL CO		037477378	manufacture(51674-0130)