Label: SPERIAN EYESALINE EYEWASH- water liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 64809-101-12, 64809-101-13, 64809-101-14, 64809-101-15, view more64809-101-16, 64809-101-21 - Packager: Sperian Eye & Face Protection Inc
- 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 September 7, 2011
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
- if solution changes color or gets cloudy
- with contact lenses
- if twist-off top is broken or missing
- in open wounds in or near the eyes
- Directions
- Other information
- Inactive ingredients
- Questions?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SPERIAN EYESALINE EYEWASH
water liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64809-101 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 99.8 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64809-101-12 30 mL in 1 BOTTLE, PLASTIC 2 NDC:64809-101-13 118 mL in 1 BOTTLE, PLASTIC 3 NDC:64809-101-14 237 mL in 1 BOTTLE, PLASTIC 4 NDC:64809-101-15 473 mL in 1 BOTTLE, PLASTIC 5 NDC:64809-101-16 946 mL in 1 BOTTLE, PLASTIC 6 NDC:64809-101-21 15 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 09/07/2011 Labeler - Sperian Eye & Face Protection Inc (013435034) Establishment Name Address ID/FEI Business Operations Sperian Eye & Face Protection Inc 013435034 manufacture Establishment Name Address ID/FEI Business Operations Medex Cardio Pulmonary dba Smiths Medical 835634168 manufacture