NDC | 70897-002-01, 70897-002-02, 70897-002-03, 70897-002-04 |
Set ID | 39a7b408-7601-2d66-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Davemed Healthcare Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART349 |
- Purpose
- Active ingredient
- Uses
- Warnings
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EYE WASH SALINE
water sodium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70897-002 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 0.9 mg in 100 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 99.01 mg in 100 mL Inactive Ingredients Ingredient Name Strength SORBIC ACID (UNII: X045WJ989B) BORIC ACID (UNII: R57ZHV85D4) SODIUM BORATE (UNII: 91MBZ8H3QO) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70897-002-01 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2016 2 NDC:70897-002-02 20 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2016 3 NDC:70897-002-03 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2016 4 NDC:70897-002-04 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 08/09/2016 Labeler - Davemed Healthcare Co., Ltd. (529128716) Establishment Name Address ID/FEI Business Operations Davemed Healthcare Co., Ltd 529128716 manufacture(70897-002)