Saline Mist

Dosage form: spray
Ingredients: SODIUM CHLORIDE 6.5mg in 1mL
Labeler: Rebel Distributors Corp
NDC Code: 21695-353

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.

Saline Mist Drug Facts

Active ingredient

Sodium Chloride 0.65%

Keep Out of Reach of Children

Uses

For dry nasal membranes squeeze twice in each nostril as needed.

Upright delivers a spray; Horizontally a stream; Upside down a drop.

Warnings

The use of this dispenser by more than one person may spread infection.

Directions

For dry nasal membranes squeeze twice in each nostril as needed.

Inactive ingredients

Purified Water, sodium chloride 0.65%, Disodium Phosphate, Phenylcarbinol, Monosodium Phosphate, Benzalkonium Chloride

Package/Label Principal Display Panel

SALINE MIST 
saline mist spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-353(NDC:45802-357)
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE6.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 
BENZYL ALCOHOL 
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:21695-353-4545 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/24/2009
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 02/2011
 
Rebel Distributors Corp

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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