Label: MAJOR LIQUITEARS- polyvinyl alcohol solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-3158-0 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0904-6492
- 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 January 18, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- Polyvinyl Alcohol
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INGREDIENTS AND APPEARANCE
MAJOR LIQUITEARS
polyvinyl alcohol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-3158(NDC:0904-6492) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL 14 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-3158-0 1 in 1 CARTON 10/10/2017 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 09/17/2015 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-3158)