Label: SIMPLE SALINE PLUS CHILDRENS COLD FORMULA PLUS MOISTURIZERS- luffa operculata, sabadilla spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated May 12, 2011

If you are a consumer or patient please visit this version.

View All Sections
  • 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-10237-696-15
    The standard of Purity            SAFE,
                                               EVERYDAY
                                               RELIEF

                            Simply
                        Saline
                           plus
                    Children's
                for children 2 years and up  

    Cold Formula
    plus Moisturizers

    moisturizes and
    clears congestion                        NASAL MIST

    HOMEOPATHIC
    1.5 FL OZ (45 mL)

    ImageImage

  • INGREDIENTS AND APPEARANCE
    SIMPLE SALINE PLUS CHILDRENS  COLD FORMULA PLUS MOISTURIZERS
    luffa operculata, sabadilla spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-696
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT6 [hp_X]  in 30 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED6 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-696-1545 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/12/2011
    Labeler - Church & Dwight Co., Inc. (001211952)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!