SALINE spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Chloride 0.65%

Available from:

Healthlife of USA

Administration route:

NASAL

Prescription type:

OTC DRUG

Therapeutic indications:

For allergies: cold, flu, sinusitis, rhinitis and dry irritated nasal passages for dry nasal membranes squeeze twice in each nostril as needed.

Authorization status:

OTC monograph final

Summary of Product characteristics

SALINE- SALINE SPRAY
HEALTHLIFE OF USA
_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 INGREDIENTS
Sodium Chloride 0.65%
PURPOSE
For allergies: cold, flu, sinusitis, rhinitis and dry irritated nasal
passages
INGREDIENTS
A solution of sodium chloride 0.65% in purified water (USP), made
isotonic with sodium phosphate
dibasic and sodium phosphate monobasic, with benzyl alcohol and
benzalkonium chloride as
preservatives.
US ES
for dry nasal membranes squeeze twice in each nostril as needed.
DIRECTIONS
upright delivers as a spray, horizontally as a stream, upside down as
a drop.
WARNINGS
IF PREGNANT OR BREAST-FEEDING,
ask a healthcare professional before use. Use of this container by
more than one person may spread infection.
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, get medical help or contact a Poison
Control Center right away.
QUESTIONS OR COMMENTS?
Call 1-844-832-1138
*This product is not manufactured or distributed by Valeant Consumer
Products, Distributors of Ocean
Saline Nasal Spray.
SALINE NASAL SPRAY
Distributed by:
Healthlife of USA
1600 Hart Street,
Rahway, NJ 07065
www.healthlifeofusa.com
SALINE
saline spray
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 517-6 0 9
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
SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)
SO DIUM PHO SPHATE, MO NO BASIC (UNII: 39 8 0 JIH2SW)
BENZYL ALCO HO L (UNII: LKG8 49 4WBH)
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 9 517-6 0 9 -19
1 in 1 CARTON
0 1/10 /20 18
Healthlife of U