SALINE MIST- saline mist spray

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

Buy It Now

Active ingredient:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)
Available from:
Rebel Distributors Corp
INN (International Name):
SODIUM CHLORIDE
Composition:
SODIUM CHLORIDE 6.5 mg in 1 mL
Administration route:
NASAL
Prescription type:
OTC DRUG
Therapeutic indications:
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
Authorization number:
21695-353-45

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

Similar products

Search alerts related to this product

Share this information