Label: GONIOSOFT - hypromelloses liquid
- NDC Code(s): 54799-503-15
- Packager: OCuSOFT, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
● For professional use in Gonioscopic examinations.Close
● For use in the eyes only. ● To avoid contamination do not touch tip of container to any surface.Close
● Replace cap after using. ● Not for use in conjunction with hot laser treatment.
- Do not use if solution changes color or becomes cloudy
- KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poision Control Center right away.Close
● Fill Gonioscopic prism with solution as necessary.Close
- Other information
● Store between 15º-30ºC (59º-86ºF). ● Keep tightly closed. ● If this solution dries on optical surfaces, let stand in cool water before cleansing.
DO NOT USE IF IMPRINTED SEAL ON CAP IS TORN, BROKEN OR MISSING.Close
- Inactive ingredients
Benzalkonium Chloride, Boric Acid, Edetate Disodium, Sodium Borate, Water for Injection, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH.Close
- Questions or Comments?
800-233-5469 or www.ocusoft.comClose
- PRINCIPAL DISPLAY PANEL
Hypromellose 2.5% Ophthalmic Demulcent Solution (Sterile)
0.5 fl oz (15mL)
Distributed by OCuSOFT Inc.
Rosenberg, TX 77471 USA
© 2011 OCuSOFT, Inc.
Trademark owned by OCuSOFT, Inc.
- INGREDIENTS AND APPEARANCE
hypromellose 2.5% liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54799-503 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hypromelloses (UNII: 3NXW29V3WO) (Hypromelloses - UNII:3NXW29V3WO) Hypromelloses 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) Boric Acid (UNII: R57ZHV85D4) Edetate Disodium (UNII: 7FLD91C86K) Sodium Borate (UNII: 91MBZ8H3QO) Water (UNII: 059QF0KO0R) Hydrochloric Acid (UNII: QTT17582CB) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54799-503-15 15 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/02/1989 Labeler - OCuSOFT, Inc. (174939207) Establishment Name Address ID/FEI Business Operations Altaire Pharmaceuticals, Inc. 786790378 MANUFACTURE(54799-503) Establishment Name Address ID/FEI Business Operations OCuSOFT, Inc. 174939207 MANUFACTURE(54799-503)