Label: SALINE MIST spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 21695-353-45 - Packager: Rebel Distributors Corp
- 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 February 21, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- PURPOSE
- Keep Out of Reach of Children
- Uses
- Warnings
- Directions
- Inactive ingredients
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
SALINE MIST
saline mist sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-353(NDC:45802-357) Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (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:21695-353-45 45 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 04/24/2009 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK
