{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "TRIMO SAN Oxyquinoline Sulfate and Sodium Lauryl Sulfate OXYQUINOLINE SULFATE OXYQUINOLINE SODIUM LAURYL SULFATE LAURYL SULFATE CITRIC ACID MONOHYDRATE SODIUM CITRATE METHYLPARABEN TROLAMINE" ], "spl_unclassified_section": [ "MX5030 ● Milex® TRIMO-SAN™ for Pessary Wearers Instructions for Use P lease 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. English RX ONLY", "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). Applicator does not lock in place . 4. Firmly hold the applicator in place above the threads. 5. Squeeze the tube from the bottom w hile firmly holding the a pplicator against the tube until TRIMO-SAN reaches the specified dosage level (see picture 2). 6. 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 INFLATOBALL or CUBE pessary, remove the pessary per physician’s instruction before using TRIMO-SAN. 7. Clean the Universal Applicator immediately after use by flushing the Universal Applicator with water several times. Pull and press plunger back and forth while holding the opening of the applicator under water. (see picture 3). Make sure that the applicator is clean and dry before reusing. 8. 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. Picture 1,2,3 Glossary of Symbols CooperSurgical CooperSurgical" ], "components": [ "C ONTENTS: 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_and_handling": [ "STORAGE: AFTER EACH USE Wipe threads of tube and the inside of the cap. RE-CAP TIGHTLY. Store at room temperature." ], "description": [ "P URPOSE 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_for_patients": [ "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." ], "warnings": [ "W ARNING: 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." ], "pregnancy": [ "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_precautions": [ "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. CooperSurgical" ], "spl_unclassified_section_table": [ "
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.
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 59365-5030-0 TRIMO-SAN VAGINAL JELLY SET with Universal Applicator CONTENTS: 1 ea. 4 oz tube (113. 4 grams) and applicator Rx Only Revised: 4/2024 PRINCIPAL DISPLAY PANEL NDC 59365-5030-0 TRIMO-SAN VAGINAL JELLY SET with Universal Applicator CONTENTS: 1 ea. 4 oz tube (113. 4 grams) and applicator Rx Only" ], "set_id": "1e4a1caa-e6ba-44ef-8347-07e6385a7c9e", "id": "545cdcec-f36b-451d-92be-8a4b21e70719", "effective_time": "20250903", "version": "13", "openfda": { "brand_name": [ "TRIMO SAN" ], "generic_name": [ "OXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATE" ], "manufacturer_name": [ "CooperSurgical, Inc." ], "product_ndc": [ "59365-5030" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "VAGINAL" ], "substance_name": [ "OXYQUINOLINE SULFATE", "SODIUM LAURYL SULFATE" ], "rxcui": [ "999638", "999640" ], "spl_id": [ "545cdcec-f36b-451d-92be-8a4b21e70719" ], "spl_set_id": [ "1e4a1caa-e6ba-44ef-8347-07e6385a7c9e" ], "package_ndc": [ "59365-5030-0" ], "is_original_packager": [ true ], "unii": [ "61VUG75Y3P", "368GB5141J" ] } } ] }