Label: TRIMO SAN- oxyquinoline sulfate and sodium lauryl sulfate jelly

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 2, 2018

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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

    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.

    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).
 

    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

    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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59365-5030
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P) (OXYQUINOLINE - UNII:5UTX5635HP) OXYQUINOLINE0.25 mg  in 1 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) (LAURYL SULFATE - UNII:DIQ16UC154) SODIUM LAURYL SULFATE0.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59365-5030-0113.4 g in 1 TUBE; Type 0: Not a Combination Product04/01/1977
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER04/01/1977
    Labeler - CooperSurgical, Inc. (801895244)