Simple Saline Cold Formula Plus Menthol: Homeopathic Product Information

SIMPLE SALINE COLD FORMULA PLUS MENTHOL- luffa operculata fruit and schoenocaulon officinale seed spray
Church & Dwight Co., Inc.

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.

Active ingredients

Luffa operculata 6X HPUS
Sabadilla 6X HPUS

Purpose

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

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 this product

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

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

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 DEA Schedule

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

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE GLYCERIN MENTHOL BENZYL ALCOHOL WATER SODIUM BICARBONATE SODIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:10237-695-30 89 mL in 1 CAN None

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)

Revised: 05/2011 Church & Dwight Co., Inc.