TRIMO SAN- oxyquinoline sulfate and sodium lauryl sulfate jelly

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P) (OXYQUINOLINE - UNII:5UTX5635HP), SODIUM LAURYL SULFATE (UNII: 368GB5141J) (LAURYL SULFATE - UNII:DIQ16UC154)

Available from:

CooperSurgical, Inc.

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 Applic

Authorization status:

unapproved drug other

Summary of Product characteristics

TRIMO SAN- OXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATE JELLY
COOPERSURGICAL, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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TRIMO SAN
MANUFACTURED FOR:
COOPERSURGICAL COMPANY
95 CORPORATE DRIVE
TRUMBULL, CT 06611
TOLL FREE: [phone]
FAX: [phone]
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:
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 h