Label: AVITEARS- polysorbate 80 solution/ drops
-
Contains inactivated NDC Code(s)
NDC Code(s): 49869-002-01, 49869-002-02 - Packager: Pinnacle Science, LLc
- 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 August 31, 2009
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
- Inactive Ingredients
- Principal Display Panel 10mL Bottle Label
- Principal Display Panel 10mL Carton Label
- Principal Display Panel 15mL Bottle Label
- Principal Display Panel 15mL Carton Label
-
INGREDIENTS AND APPEARANCE
AVITEARS
polysorbate 80 solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49869-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength polysorbate 80 (UNII: 6OZP39ZG8H) (polysorbate 80 - UNII:6OZP39ZG8H) polysorbate 80 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength sodium citrate (UNII: 1Q73Q2JULR) sodium chloride (UNII: 451W47IQ8X) citric acid monohydrate (UNII: 2968PHW8QP) mannitol (UNII: 3OWL53L36A) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49869-002-02 10 mL in 1 BOTTLE, PLASTIC 2 NDC:49869-002-01 15 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 07/17/2009 Labeler - Pinnacle Science, LLc (828202494)
