Label: EYE WASH SALINE- water sodium chloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 70897-002-01, 70897-002-02, 70897-002-03, 70897-002-04 - Packager: Davemed Healthcare Co., Ltd.
- 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 February 3, 2020
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- 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)
