NDC | 15821-101-15 |
Set ID | 6397ebc5-0670-4dc0-8660-6c0f733e6fd1 |
Category | HUMAN OTC DRUG LABEL |
Packager | FOCUS Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART349 |
- FreshKote Lubricant Eye Drops Doctor Recommended
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- Drug Facts
- Active ingredients
- PURPOSE
- Uses
-
Warnings
For external use only.
Do not use if:
- solution changes color or becomes cloudy.
- you are sensitive to any ingredient in this product.
When using this product:
- Do not touch tip of container to any surface to avoid contamination.
- Replace cap after using.
Stop use and ask a doctor if:
- you experience eye pain.
- you experience changes in vision.
- you experience continued redness or irritation.
- the condition worsens.
- symptoms last more than 72 hours.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients:
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FRESHKOTE LUBRICANT EYE DROPS
povidone/polyvinyl alcohol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15821-101 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE K29/32 (UNII: 390RMW2PEQ) (POVIDONE K29/32 - UNII:390RMW2PEQ) POVIDONE K29/32 20 g in 1000 mL POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL 27 g in 1000 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) POTASSIUM CHLORIDE (UNII: 660YQ98I10) POLIXETONIUM (UNII: EJT309W86C) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM CHLORIDE (UNII: 451W47IQ8X) EDETATE DISODIUM (UNII: 7FLD91C86K) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15821-101-15 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 04/01/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 04/01/2006 Labeler - FOCUS Laboratories, Inc. (926378337) Registrant - FOCUS Laboratories, Inc. (926378337) Establishment Name Address ID/FEI Business Operations Altaire Pharmaceutical 786790378 analysis(15821-101) , label(15821-101) , manufacture(15821-101) , pack(15821-101) , sterilize(15821-101)