Label: BREATHE THE SEA ALL-NATURAL SEAWATER- sodium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 52429-124-01 - Packager: Nasal and Sinus Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 17, 2012
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- Official Label (Printer Friendly)
- PURPOSE
- DIRECTIONS
- PRECAUTIONS
- CAUTION
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
- INGREDIENTS
- PRINCIPAL DISPLAY PANEL - 125 mL Canister Label
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INGREDIENTS AND APPEARANCE
BREATHE THE SEA ALL-NATURAL SEAWATER
sodium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52429-124 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride 2600 mg in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52429-124-01 125 mL in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 03/01/2012 Labeler - Nasal and Sinus Health, Inc. (968415740) Establishment Name Address ID/FEI Business Operations Nasal and Sinus Health, Inc. 968415740 RELABEL Establishment Name Address ID/FEI Business Operations Gerolymatos International 423075886 MANUFACTURE