| Product NDC: | 11716-1163 |
| Proprietary Name: | LEADER EYE ITCH RELIEF DROPS |
| Non Proprietary Name: | KETOTIFEN FUMARATE |
| Active Ingredient(s): | .345 mg/mL & nbsp; KETOTIFEN FUMARATE |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SOLUTION/ DROPS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 11716-1163 |
| Labeler Name: | HANLIM PHARM. CO., LTD. |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | part349 |
| Marketing Category: | OTC MONOGRAPH FINAL |
| Start Marketing Date: | 20100421 |
| Package NDC: | 11716-1163-7 |
| Package Description: | 1 BOTTLE in 1 CARTON (11716-1163-7) > 5 mL in 1 BOTTLE |
| NDC Code | 11716-1163-7 |
| Proprietary Name | LEADER EYE ITCH RELIEF DROPS |
| Package Description | 1 BOTTLE in 1 CARTON (11716-1163-7) > 5 mL in 1 BOTTLE |
| Product NDC | 11716-1163 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | KETOTIFEN FUMARATE |
| Dosage Form Name | SOLUTION/ DROPS |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 20100421 |
| Marketing Category Name | OTC MONOGRAPH FINAL |
| Labeler Name | HANLIM PHARM. CO., LTD. |
| Substance Name | KETOTIFEN FUMARATE |
| Strength Number | .345 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes |