RELEGARD THERAPEUTIC VAGINAL GEL WITH APPLICATOR

Manufacturer: BLANSETT PHARMACAL CO
Effective date: 2017-03-20
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:23:39

Label at a glance#

ProductRELEGARD

Active ingredientACETIC ACID, OXYQUINOLINE

Label structure7 sections

Dosage and administration

TO OPEN: USE TOP OF CAP TO TWIST OFF SEAL. FOR VAGINAL USE ONLY.

Label contents#

Full prescribing information#

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Relagard proof 7.25.02_Page_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
543873	acetic acid 0.9 % / oxyquinoline sulfate 0.025 % Vaginal Gel	PSN	1
543879	Relagard 0.9 % / 0.025 % Vaginal Gel	PSN	1
543879	acetic acid 0.009 MG/MG / oxyquinoline sulfate 0.00025 MG/MG Vaginal Gel [Relagard]	SBD	1
543873	acetic acid 0.009 MG/MG / oxyquinoline sulfate 0.00025 MG/MG Vaginal Gel	SCD	1
543873	acetic acid 0.9 % / oxyquinoline sulfate 0.025 % Vaginal Gel	SY	1
543879	Relagard (acetic acid 0.9 % / oxyquinoline sulfate 0.025 % ) Vaginal Gel	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51674-0130-5	2020-01-31	C162847	48780-1	9d75b9d1-058e-f424-e053-dadaa90a57ce	RELEGARD THERAPEUTIC VAGINAL GEL WITH APPLICATOR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51674-0130-5	RELEGARD	50 mL in 1 TUBE	GEL	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51674-0130	RELEGARD (GLACIAL ACETIC ACID, OXYQUINOLINE) GEL [BLANSETT PHARMACAL CO]	1	Legacy NDC, 1 package rows	20170321_dd1b4ad8-08f2-4412-8a98-2d82ef35f053.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51674-0130-5	GM - Gram	51674-0130	ad49490d-c89d-49ee-b076-9c99addf1088	1	2017-04-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

RELEGARD
GLACIAL ACETIC ACID, OXYQUINOLINE
ACETIC ACID
OXYQUINOLINE
GLYCERIN
LACTIC ACID
POLYETHYLENE GLYCOL 4500
WATER
POTASSIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51674-0130	51674-0130-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETIC ACID	Q40Q9N063P	ACTIB
OXYQUINOLINE	5UTX5635HP	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
LACTIC ACID	33X04XA5AT	IACT
POLYETHYLENE GLYCOL 4500	TVH7653921	IACT
WATER	059QF0KO0R	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
85f9ed27-9fce-4cd5-9cb2-7dc9d6c06cb1			dd1b4ad8-08f2-4412-8a98-2d82ef35f053	2017-03-20		Exact identifier spl id: 85f9ed27-9fce-4cd5-9cb2-7dc9d6c06cb1 spl set id: dd1b4ad8-08f2-4412-8a98-2d82ef35f053

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.