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Relagard Vaginal Gel Prescribing Information

Package insert / product label
Generic name: glacial acetic acid, oxyquinoline
Dosage form: vaginal gel
Drug class: Topical anti-infectives

Medically reviewed by Drugs.com. Last updated on Mar 1, 2024.

Relagard Vaginal Gel Dosage and Administration

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

FOR VAGINAL USE ONLY.

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.

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.

STORE AT ROOM TEMPERATURE.

DO NOT TAKE BY MOUTH OR USE IN EYES.

COMPLETE PRESCRIBING INFORMATION IS ENCLOSED.

THIS BOX CONTAINS ONE APPLICATOR.

Relagard proof 7.25.02_Page_1

RELAGARD
glacial acetic acid, oxyquinoline gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51674-0130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID0.9 mg in 1 mL
OXYQUINOLINE (UNII: 5UTX5635HP) (OXYQUINOLINE - UNII:5UTX5635HP) OXYQUINOLINE0.025 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)
WATER (UNII: 059QF0KO0R)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51674-0130-550 mL in 1 TUBE; Type 0: Not a Combination Product03/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/20/2017
Labeler - BLANSETT PHARMACAL CO (037477378)
Establishment
NameAddressID/FEIBusiness Operations
BLANSETT PHARMACAL CO037477378manufacture(51674-0130)