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 Type HUMAN OTC DRUG Item Code (Source) NDC:54705-160
Route of Administration NASAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 3 [hp_X]  in 20 mL
EUCALYPTUS GLOBULUS WHOLE (EUCALYPTUS GLOBULUS WHOLE) EUCALYPTUS GLOBULUS WHOLE 3 [hp_X]  in 20 mL
MENTHOL (MENTHOL) MENTHOL 4 [hp_X]  in 20 mL
SAMBUCUS NIGRA WHOLE (SAMBUCUS NIGRA WHOLE) SAMBUCUS NIGRA WHOLE 2 [hp_X]  in 20 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 3 [hp_X]  in 20 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
ALCOHOL  
XYLITOL  
POLOXAMER 407  
GLYCERIN  
SORBITOL  
SODIUM CHLORIDE  
CITRIC ACID MONOHYDRATE  
SODIUM BENZOATE  
THYMOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54705-160-01 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY (54705-160-20)
1 NDC:54705-160-20 20 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (54705-160-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 12/18/2012

Labeler - Flutrends International Corporation (054162682)
Establishment
Name Address ID/FEI Operations
Humco Holding Group, Inc. 825672884 manufacture

Revised: 12/2012 Flutrends International Corporation