SALINE NASAL 3OZ- sodium chloride 0.65% spray

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)

Disponível em:

Lee Pharmaceuticals

DCI (Denominação Comum Internacional):

SODIUM CHLORIDE

Composição:

SODIUM CHLORIDE 6.5 mg in 1 mL

Via de administração:

NASAL

Tipo de prescrição:

OTC DRUG

Indicações terapêuticas:

Moisturizer For dry nasal membranes

Status de autorização:

OTC monograph final

Características técnicas

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._
----------
_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