SALINE MIST spray

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Rebel Distributors Corp

INN:

SODIUM CHLORIDE

composition:

SODIUM CHLORIDE 6.5 mg in 1 mL

administration_route:

NASAL

prescription_type:

OTC DRUG

therapeutic_indication:

For dry nasal membranes squeeze twice in each nostril as needed. Upright delivers a spray; Horizontally a stream; Upside down a drop.

authorization_status:

OTC monograph final

SPC

SALINE MIST- SALINE MIST SPRAY
REBEL DISTRIBUTORS CORP
_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
US ES
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
Rebel Distributors Corp
SALINE MIST
saline mist spray
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:216 9 5-353(NDC:458 0 2-357)
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
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: 9 4255I6 E2T)
BENZYL ALCO HO L (UNII: LKG8 49 4WBH)
SO DIUM PHO SPHATE, MO NO BASIC ANHYDRO US (UNII: KH7I0 4HPUU)
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:216 9 5-353-45
45 mL in 1 BOTTLE
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
0 4/24/20 0 9
LABELER -
Rebel Distributors Corp (118802834)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Rebel Distributo rs Co rp
118 8 0 28 34
RELABEL, REPACK
Revised: 2/2011