MARIMER HYPERTONIC SEAWATER NASAL- seawater nasal spray spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)

Available from:

LABORATOIRES GILBERT

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

1.for the cleansing of the nasal airways 2.for the decongestion of the blocked nose, 3.in complement to the treatments of ENT disorders. recommended for children and adults for the cleansing

Authorization status:

unapproved homeopathic

Summary of Product characteristics

MARIMER HYPERTONIC SEAWATER NASAL- SEAWATER NASAL SPRAY SPRAY
LABORATOIRES GILBERT
_Disclaimer: This homeopathic product has not been evaluated by the
Food and Drug_
_Administration for safety or efficacy. FDA is not aware of scientific
evidence to support_
_homeopathy as effective._
----------
Marimer Hypertonic is recommended for children and adults for the
cleansing and the
decongestioning of the nasal airways, in particular in case of cold
and sinusitis.
water
1.for the cleansing of the nasal airways
2.for the decongestion of the blocked nose,
3.in complement to the treatments of ENT disorders.
2.2% sodium chloride
KEEP OUT OFTHE SIGHT AND REACH OF CHILDREN
recommended for children and adults for the cleansing
Do not expose to temperatures exceeding 50°C/122°F
May burst if heated.Keep away from heat, sparks, open flames, hot
surfaces and any
other sources of ignition. No smoking. Do not pierce or burn, even
after use.Protect
from sunlight. Do not expose to temperatures exceeding 5o°C/122°F.
KEEP OUT OFTHE
SIGHT AND REACH OF CHILDREN. Do not use after the expiry date
indicated on the box.
MARIMER HYPERTONIC SEAWATER NASAL
seawater nasal spray spray
LABORATOIRES GILBERT
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:82138-001
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION -
UNII:LYR4M0NH37)
SODIUM CHLORIDE
2.2 g in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:82138-001-
01
100 mL in 1 BOTTLE; Type 0: Not a Combination
Product
08/03/2021
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
unapproved
homeopathic
08/03/2021
LABELER -
LABORATOIRES GILBERT (262619455)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
LABORATOIRES GILBERT
262619455
manufacture(82138-001)
Revised: 8/2021