FluNada Cold and Flu Relief - Drug Facts Label

FLU NADA COLD AND FLU RELIEF - eucalyptol, eucalyptus globulus whole, menthol, sambucus nigra whole and methyl salicylate spray, metered 
Flutrends International Corporation

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.

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Active Ingredients: (in each 20 mL)

Eucalyptol 3x HPUS

Eucalyptus globulus 3x HPUS

Mentholum 4x HPUS

Sambucus nigra 2x HPUS

Gaultheria 3x HPUS

Purpose

The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

Store at room temperature in a cool, dry place

Uses:

For relief of cold and flu-like symptoms such as nasal congestion, runny or blocked nose, post nasal drip, sore throat, cough and headache. For optimal results, use at first sign of cold or flu-like symptoms.

Warnings:

Directions:

Inactive Ingredients:

Water, ethanol, xylitol, poloxamer 407, glycerin, sorbitol, sodium chloride, citric acid, sodium benzoate, thymol.

FOR QUESTIONS / COMMENTS:

call (888) 407-2816

www.flunada.com

Image of Label and Outer Carton

FluNadaLabel.jpgLabel FluNadaCarton.jpgCarton


FLU NADA  COLD AND FLU RELIEF
eucalyptol, eucalyptus globulus whole, menthol, sambucus nigra whole, methyl salicylate spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54705-160
Route of AdministrationNASAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL3 [hp_X]  in 20 mL
EUCALYPTUS GLOBULUS WHOLE (EUCALYPTUS GLOBULUS WHOLE) EUCALYPTUS GLOBULUS WHOLE3 [hp_X]  in 20 mL
MENTHOL (MENTHOL) MENTHOL4 [hp_X]  in 20 mL
SAMBUCUS NIGRA WHOLE (SAMBUCUS NIGRA WHOLE) SAMBUCUS NIGRA WHOLE2 [hp_X]  in 20 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE3 [hp_X]  in 20 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
XYLITOL 
POLOXAMER 407 
GLYCERIN 
SORBITOL 
SODIUM CHLORIDE 
CITRIC ACID MONOHYDRATE 
SODIUM BENZOATE 
THYMOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:54705-160-011 BOTTLE, SPRAY in 1 CARTONcontains a BOTTLE, SPRAY (54705-160-20)
1NDC:54705-160-2020 mL in 1 BOTTLE, SPRAYThis package is contained within the CARTON (54705-160-01)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/18/2012

Labeler - Flutrends International Corporation (054162682)
Establishment
NameAddressID/FEIOperations
Humco Holding Group, Inc.825672884manufacture

Revised: 12/2012 Flutrends International Corporation