SIMPLE SALINE- luffa operculata, sabadilla spray

Simple Saline by

Drug Labeling and Warnings

Simple Saline by is a Homeopathic medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Luffa operculata 6X HPUS
Sabadilla 6X HPUS

Purpose

Luffa operculata 6X HPUS - Runny nose, nasal dryness, sinus congestion, post-nasal drip

Sabadilla 6X HPUS - Sneezing, runny nose, itching

Uses

according to homeopathic principles, the active ingredients in this medication temporarily relieve symptoms of:

• nasal congestion
• runny nose due to colds and flu
• post-nasal drip
• dry, irritated nasal passages
• sinus congestion and pressure
  

Warnings

Ask a doctor before use if you

• are prone to ear, nose or throat sensitivity
• are susceptible to nose bleeds
  

WHEN USING

When using this product

• contents under pressure
• do not puncture or incinerate
• store between 59 and 86F (15 and 30C)
• avoid spraying in eyes

STOP USE

Stop use and consult a doctor if symptoms persist beyond 7 days or worsen

• initial exacerbation of symptoms may occur
• the use of this container by more than one person may spread infection
  

KEEP OUT OF REACH OF CHILDREN

If pregnant or breast feeding, as a health professional before use.

KEEP OUT OF THE REACH OF CHILDREN.

Directions

for adults and children 2 years and older. Simply Saline Nasal Mist can be used as often as necessary.  Non-habit forming.

• to flush and irrigate, tilt head to the side over sink.  Insert nozzle into one nostril, depressing as a gentle mist fills sinus passages and flows out nostrils.  OR,
• to moisturize and relieve congestion, insert nozzle into each nostril and press shortly as moisture is restored to dry nasal passages.

Other information

active ingredients are microdiluted in accordance with the Homeopathic Pharmacopoeia of the Untied States and are therefore non-toxic and have no know side effect

Inactive ingredients

benzalkonium chloride, glycerin, menthol, phenylcarbinol, purified water, sodium bicarbonate, sodium chloride

Product Image

Arm and Hammer                                             NDC-10237-695-30
The standard of Purity            SAFE,
                                           EVERYDAY
                                           RELIEF

                        Simply
                    Saline
                       plus
Cold Formula
plus Menthol

moisturizes and
clears congestion                        NASAL MIST

HOMEOPATHIC
3 FL OZ (89 mL)

Image

INGREDIENTS AND APPEARANCE

SIMPLE SALINE   COLD FORMULA PLUS MENTHOL
luffa operculata, sabadilla spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-695
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	6 [hp_X]  in 30 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	6 [hp_X]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-695-30	89 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/12/2011

Labeler - Church & Dwight Co., Inc. (001211952)