SALINE NASAL - saline nasal spray
Physicians Total Care, Inc.

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 Nasal Spray 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

NDC 54868-1947-0

Saline Nasal Spray - 0.65%

sodium chloride

45 mL

Saline Nasal Spray 0.65%

SALINE NASAL
saline nasal spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54868-1947(NDC:45802-357)
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS (UNII: KH7I04HPUU)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54868-1947-0	45 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	12/27/2002

Labeler - Physicians Total Care, Inc. (194123980)

Name	Address	ID/FEI	Business Operations
Establishment
Physicians Total Care, Inc.		194123980	relabel(54868-1947)