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 CooperSurgical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Manufactured for:

CooperSurgical Company

95 Corporate Drive

Trumbull, CT 06611

Toll Free: (800) 243-2974

Fax: (800) 262-0105

www.coopersurgical.com

TRIMO-SAN – REF MX5030

For Pessary Wearers - A Vaginal Product

Rx Only

PLEASE READ CAREFULLY

A pessary is considered a foreign body in the vagina. For long-term pessary users, it is important to maintain the normal acidic pH of the vagina. TRIMO-SAN, a deodorant vaginal gel, may help pessary wearers restore and maintain a normal acidic pH of the vagina.

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.

PURPOSE OF TRIMO-SAN      

1. To help restore and maintain normal vaginal acidity.

2.  To coat walls of vagina with a lubricating film that may help reduce odor-causing bacteria, since bacteria can flourish in abnormal vaginal pH.

INFORMATION ABOUT TRIMO-SAN

1. TRIMO-SAN Gel will not stain skin or natural fabrics.

2. TRIMO-SAN Gel helps eliminate odors, which may be associated with wearing a pessary.

3. Dosage of TRIMO-SAN Gel may be adjusted from one-half an applicator to a full applicator to obtain the desired results without messy leakage.

WARNING:  

Chemicals in various preparations can interact with the pessary material resulting in discoloration or deterioration of the pessary.

TRIMO-SAN does not have a deleterious effect on any Milex pessary. Testing should be performed before using any other vaginal preparation with a pessary unless specifically prescribed by your healthcare professional.

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

• New pessary wearers should use a ½ applicator of TRIMO-SAN 3 times the first week after original insertion of pessary.
  
• Use TRIMO-SAN ½ applicator twice a week thereafter unless otherwise directed by your healthcare professional.
  
• Reaction or irritation caused by TRIMO-SAN is very rare, but should it occur, discontinue use.
  
• If symptoms persist or worsen, contact your healthcare professional

THIS PRODUCT IS INTENDED FOR MULTIPLE USE BY ONE PATIENT ONLY.

PROPER USE OF MILEX JEL-JECTOR

1. Unscrew cap from tube

2. Pierce end of tube with top of cap (a small amount of TRIMO-SAN may escape when top of tube is pierced).

3. Attach threaded end of Milex Jel-Jector to TRIMO-SAN tube (see ①).

4. While holding tube with attached Milex Jel-Jector (see ②), squeeze tube from bottom until TRIMO-SAN reaches specified dosage level.

5. Detach Milex Jel-Jector from tube. Gently insert Jel-Jector approximately ½ inch into the vagina. Squeeze bulb vigorously once to dispense gel. Keep bulb compressed until the Milex Jel-Jector is removed from the vagina.

NOTE: For those wearing an Inflat-o-ball or Cube Pessary, remove pessary per physician’s instruction before application of TRIMO-SAN.

6. Clean Milex Jel-Jector immediately after use by flushing Jector (compressing bulb) several times, holding Jel-Jector under water (see ③).

NOTE: The “pin” hole at the top of the bulb is an air release hole. Do NOT tape over this hole or otherwise block this hole. This “pin” hole is not a defect in the bulb.

7. After each use, wipe threads of tube and inside of cap. Recap tightly.

 

IMPORTANT IF YOU HAVE ANY OF THE FOLLOWING SIGNS OR SYMPTOMS, CONSULT A HEALTHCARE PROFESSIONAL

A. A discharge, which is unusual in color, consistency or amount.

B. A burning or itching sensation in the vaginal area.

C. A foul odor associated with vaginal discharge.

D. Any of the above especially if accompanied by unusual swelling or tenderness, fever, pains or cramps in the lower abdomen.

NOTE

If this product is being used with a pessary, follow your healthcare professional’s instructions explicitly. Consult your health care professional for all other medically-related advice.

PRINCIPAL DISPLAY PANEL

NDC: 59365-5030-0
TRIMO-SAN
VAGINAL JELLY SET
with Nylon Milex Jel-Jector
CONTENTS: 1 ea. 4 oz tube (113. 4 grams)and applicator
Rx Only

Revised: 4/2018

INGREDIENTS AND APPEARANCE

TRIMO SAN 
oxyquinoline sulfate and sodium lauryl sulfate jelly

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59365-5030
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)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
METHYLPARABEN (UNII: A2I8C7HI9T)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59365-5030-0	113.4 g in 1 TUBE; Type 0: Not a Combination Product	04/01/1977

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		04/01/1977

Labeler - CooperSurgical, Inc. (801895244)