Label: TEARS RENEWED LUBRICANT- dextran 70 solution
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Contains inactivated NDC Code(s)
NDC Code(s): 68788-0039-1 - Packager: Preferred Pharmaceuticals, Inc
- This is a repackaged label.
- Source NDC Code(s): 17478-061
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 6, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- DOSAGE & ADMINISTRATION
-
INGREDIENTS AND APPEARANCE
TEARS RENEWED LUBRICANT
dextran 70 solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0039(NDC:17478-061) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 70 0.001 mL in 1 mL HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES 0.003 mL in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) BORIC ACID (UNII: R57ZHV85D4) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-0039-1 15 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 11/16/2010 Labeler - Preferred Pharmaceuticals, Inc (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc 791119022 relabel