Label: WINCO FOODS SALINE NASAL RELIEF- sodium chloride spray
- NDC Code(s): 67091-327-46
- Packager: WinCo Foods, LLC
- 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 August 2, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions:
For children and adults, squeeze bottle twice in each nostril as often as needed or as directed by physician.
For Infants,
use drop application. Hold bottle upright for spray, horizontally for stream, and upside down for drop.
The use of this dispenser by more than one person may spread infection.
Store at room temperature
- Questions
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DOSAGE & ADMINISTRATION
WinCo® Foods
Saline Nasal Spray
Sodium Chloride / Moisturizer
Instantly Soothes & Moisturizes
Dry Nasal Passages
Non –Medicated Nasal Relief
1.5FL OZ (45 mL)
*Compare to the active ingredient in OCEAN® Saline Nasal Spray
DISTRIBUTED BY:
WINCO FOODS, LLC,
BOISE, ID 83704
Do not use if imprinted seal around cap is broken or missing,
*This product is not manufactured or distributed by VALEANT CONSUMER PRODUCTS, a division of VALEANT PHARMACEUTICALS, distributor of OCEAN® saline Nasal Spray.
100% SATIFACTION GUARANTEE
Comments & Questions? 800-824-1706
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WINCO FOODS SALINE NASAL RELIEF
sodium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-327 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE .65 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-327-46 45 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 08/01/2018 Labeler - WinCo Foods, LLC (056098817)
