Label: TRIMO SAN- oxyquinoline sulfate and sodium lauryl sulfate jelly
- NDC Code(s): 59365-5030-0
- Packager: CooperSurgical, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated June 17, 2022
If you are a consumer or patient please visit this version.
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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
MX5030 MILEX® TRIMO-SAN™ FOR PESSARY WEARERS
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:
- STORAGE:
- PURPOSE OF TRIMO-SAN
- INFORMATION ABOUT TRIMO-SAN
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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.
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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.
- CooperSurgical does not recommend the use of TRIMO-SAN during pregnancy.
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GENERAL INFORMATION
- New pessary wearers should use a ½ applicator (2g) of TRIMO-SAN 3 times the first week after original insertion of pessary.
- Use TRIMO-SAN ½ (2g) 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.
- New pessary wearers should use a ½ applicator (2g) of TRIMO-SAN 3 times the first week after original insertion of pessary.
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PROPER USE OF UNIVERSAL APPLICATOR
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 the universal applicator to TRIMO-SAN tube (see picture 1).
4. While holding the Universal Applicator, squeeze the tube from the bottom until TRIMO-SAN reaches the specified dosage level (see picture 2).
5. Detach the Universal Applicator from the tube. Gently insert the Universal Applicator approximately ½ inch into the vagina.
Press in the plunger of the Universal Applicator to dispense the gel.
Keep the plunger pressed until the Universal Applicator 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 the Universal Applicator immediately after using by flushing the Universal Applicator (pull and press plunger back and forth) several times, holding the Universal Applicator under water (see picture 3).
Make sure that the Universal Applicator is clean and dry before reusing.
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
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INGREDIENTS AND APPEARANCE
TRIMO SAN
oxyquinoline sulfate and sodium lauryl sulfate jellyProduct 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)