FDA.reportPublic FDA data

TRIMO SAN

Manufacturer
CooperSurgical, Inc.
Effective date
2025-09-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-05-31 21:41:23

Label at a glance#

ProductTRIMO SAN
Active ingredientOXYQUINOLINE SULFATE, SODIUM LAURYL SULFATE
Label structure10 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

EnglishEnglish RX ONLYRX ONLY

MX5030 ● Milex® TRIMO-SAN™ for Pessary Wearers

Instructions for Use

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:  

COMPONENTS

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:

STORAGE AND HANDLING SECTION

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

PURPOSE OF TRIMO-SAN

DESCRIPTION SECTION

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

INFORMATION FOR PATIENTS SECTION

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:  

WARNINGS SECTION

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

PREGNANCY SECTION

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

GENERAL PRECAUTIONS SECTION

  • 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.

CooperSurgicalCooperSurgical

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

PROPER USE OF UNIVERSAL APPLICATOR

SPL UNCLASSIFIED SECTION

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 1,2,3Picture 1,2,3

Glossary of SymbolsGlossary of Symbols

CooperSurgicalCooperSurgical

CooperSurgicalCooperSurgical

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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

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 OnlyPRINCIPAL 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

     

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
999638oxyquinoline sulfate 0.025 % / sodium lauryl sulfate 0.01 % Vaginal GelPSN13
999640TRIMO-SAN 0.025 % / 0.01 % Vaginal GelPSN13
999640oxyquinoline sulfate 0.00025 MG/MG / sodium dodecyl sulfate 0.0001 MG/MG Vaginal Gel [Trimo San]SBD13
999638oxyquinoline sulfate 0.00025 MG/MG / sodium dodecyl sulfate 0.0001 MG/MG Vaginal GelSCD13
999638oxyquinoline sulfate 0.025 % / sodium lauryl sulfate 0.01 % Vaginal GelSY13
999640Trimo San (oxyquinoline sulfate 0.025 % / sodium lauryl sulfate 0.01 % ) Vaginal GelSY13

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59365-5030-02020-04-15C16284748780-19d75b9d0-2596-f424-e053-dadaa90a57ceTrimo San
59365-5030-02020-01-31C16284748780-19d75b9d0-2596-f424-e053-dadaa90a57ceTrimo San

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59365-5030-0TRIMO SAN113.4 g in 1 TUBEJELLY113.413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59365-5030-0GM - Gram59365-50301ac30744-5459-49a6-b3a2-e34fbc023e6512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OXYQUINOLINE SULFATEACTIVE INGREDIENT61VUG75Y3P6
SODIUM LAURYL SULFATEACTIVE INGREDIENT368GB5141J6
LAURYL SULFATEACTIVE MOIETYDIQ16UC1546
OXYQUINOLINEACTIVE MOIETY5UTX5635HP6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR6
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59365-503059365-5030-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYQUINOLINE SULFATE61VUG75Y3PACTIM
SODIUM LAURYL SULFATE368GB5141JACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
METHYLPARABENA2I8C7HI9TIACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii+route
12 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / VAGINAL0.49 %w/wExact identifier — unii+route
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii+route
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii+route
12 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii+route
4 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii+route
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii+route
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii+route
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii+route
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii+route
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii+route
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / VAGINAL0.49 %w/wExact identifier — unii+route
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii+dosage form
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii+route
12 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii+route
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii+route
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii+route
12 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
ndc (package): 59365-5030-0
ndc (product): 59365-5030
ndc11 (package): 59365503000
spl id: 545cdcec-f36b-451d-92be-8a4b21e70719
spl set id: 1e4a1caa-e6ba-44ef-8347-07e6385a7c9e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.