Label: SALINE NASAL spray
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-1947-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 45802-357
- 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 July 12, 2012
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- Official Label (Printer Friendly)
- Active ingredient
- PURPOSE
- Keep Out of Reach of Children
- Uses
- Warnings
- Directions
- Inactive ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
SALINE NASAL
saline nasal sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-1947(NDC:45802-357) Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM PHOSPHATE, MONOBASIC ANHYDROUS (UNII: KH7I04HPUU) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-1947-0 45 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 12/27/2002 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel(54868-1947)
