SALINE NASAL 3OZ- sodium chloride 0.65% spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)
Available from:
Lee Pharmaceuticals
INN (International Name):
SODIUM CHLORIDE
Composition:
SODIUM CHLORIDE 6.5 mg in 1 mL
Administration route:
NASAL
Prescription type:
OTC DRUG
Therapeutic indications:
Moisturizer For dry nasal membranes
Authorization status:
OTC monograph final
Authorization number:
23558-6895-1

SALINE NASAL 3OZ- sodium chloride 0.65% spray

Lee Pharmaceuticals

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.

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Drug Facts

Active ingredient

Sodium Chloride, 0.65%

Purpose

Moisturizer

Uses

For dry nasal membranes

Warnings

Do not use if seal is broken or missing.

Keep out of reach of children. The use of this dispenser by more than one person may spread

infection.

Directions

Squeeze twice in each nostril as needed

Upright delivers a spray, horizontally a stream, upside down a drop

Inactive ingredients

Benzalkonium chloride, Disodium phosphate, Phenylcarbinol, Monosodium phosphate, Water

Lee Pharmaceuticals

SALINE NASAL 3OZ

sodium chloride 0.65% spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:23558 -6 8 9 5

Route of Administration

NASAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

SODIUM CHLORIDE

6 .5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

SO DIUM PHO SPHATE, DIBASIC ANHYDRO US (UNII: 22ADO53M6 F)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

SO DIUM PHO SPHATE, MO NO BASIC, ANHYDRO US (UNII: KH7I0 4HPUU)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:23558 -6 8 9 5-1

8 8 mL in 1 BOTTLE, SPRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt349

10 /0 1/20 13

Labeler -

Lee Pharmaceuticals (056425432)

Registrant -

Lee Pharmaceuticals (056425432)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Lee Pharmaceuticals

0 56 425432

ma nufa c ture (23558 -6 8 9 5)

Revised: 11/2013

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