TRIMO-SAN- oxyquinoline sulfate and sodium lauryl sulfate jelly

Trimo-San by

Drug Labeling and Warnings

Trimo-San by is a Prescription medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CONTENTS

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

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

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

Labeler - Denison Pharmaceuticals, LLC (001207208)

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