Label: TRIMO-SAN- oxyquinoline sulfate and sodium lauryl sulfate jelly
- NDC Code(s): 0295-5030-18
- Packager: Denison Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated September 11, 2019
If you are a consumer or patient please visit this version.
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.
- GENERAL INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
oxyquinoline sulfate and sodium lauryl sulfate jelly
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0295-5030 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) METHYLPARABEN (UNII: A2I8C7HI9T) TROLAMINE (UNII: 9O3K93S3TK) SODIUM CITRATE (UNII: 1Q73Q2JULR) CARBOMER 934 (UNII: Z135WT9208) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0295-5030-18 113.4 g in 1 TUBE; Type 0: Not a Combination Product 09/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/16/2019 Labeler - Denison Pharmaceuticals, LLC (001207208) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC 001207208 manufacture(0295-5030)