TRIMO-SAN- oxyquinoline sulfate and sodium lauryl sulfate jelly
Denison Pharmaceuticals, LLC

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.

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Trimo San

Hydroxyquinoline Sulfate 0.025%; Sodium Lauryl Sulfate N.F. 0.01%. Adjusted with Triethanolamine to pH 4 in water dispersible base composed of Glycerine, Carbomer N.F., Citric Acid, Sodium Citrate U.S.P., Methylparaben N.F., Perfume and Antifoam Emulsion N.F.

STORAGE:

AFTER EACH USE Wipe threads of tube and the inside of the cap. RE-CAP TIGHTLY. Store at room temperature.

TRIMO-SAN and PREGNANCY

TRIMO-SAN has NOT been tested for use during pregnancy.

CooperSurgical does not recommend the use of TRIMO-SAN during pregnancy.
If you wish to become pregnant, do not use TRIMO-SAN or any other personal hygiene product vaginally (douches, vaginal sprays, jellies or suppositories), for 6 hours prior to or following intercourse. Any product used within this time period could interfere with conception.

GENERAL INFORMATION

Use Cap to pierce seal in head of tube

Instructions for use inside package

Keep this product out of the reach of children

PRINCIPAL DISPLAY PANEL

label

TRIMO-SAN
oxyquinoline sulfate and sodium lauryl sulfate jelly

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0295-5030
Route of Administration	VAGINAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P) (OXYQUINOLINE - UNII:5UTX5635HP)	OXYQUINOLINE	0.25 mg in 1 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J) (LAURYL SULFATE - UNII:DIQ16UC154)	SODIUM LAURYL SULFATE	0.1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CARBOMER 934 (UNII: Z135WT9208)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0295-5030-18	113.4 g in 1 TUBE; Type 0: Not a Combination Product	09/16/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/16/2019

Labeler - Denison Pharmaceuticals, LLC (001207208)

Name	Address	ID/FEI	Business Operations
Establishment
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-5030)

Trimo San

CONTENTS

STORAGE:

TRIMO-SAN and PREGNANCY

GENERAL INFORMATION

PRINCIPAL DISPLAY PANEL