RELEGARD

RELEGARD- acetic acid and oxyquinoline gel
BLANSETT PHARMACAL CO

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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
(click image for full-size original)

RELEGARD
glacial acetic acid, oxyquinoline gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51674-0130
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETIC ACID (ACETIC ACID) ACETIC ACID 0.9 mg in 1 mL
OXYQUINOLINE (OXYQUINOLINE) OXYQUINOLINE 0.025 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
LACTIC ACID
POLYETHYLENE GLYCOL 4500
WATER
POTASSIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51674-0130-5 50 mL in 1 TUBE None
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 Operations
BLANSETT PHARMACAL CO 037477378 manufacture (51674-0130)

Revised: 03/2017 BLANSETT PHARMACAL CO

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