COLD-EEZE MINT  - zinc gluconate spray 
ProPhase Labs, 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.

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Active Ingredient (2 sprays) Zincum Gluconicum 2x (13.3mg)

Active Ingredient (2 sprays)                          Purpose
Zincum Gluconicum 2x (13.3mg)......................Cold Remedy

Keep out of reach of children.

COLD-EEZE Oral Spray is formulated to reduce the duration of common cold symptoms and may be insufficient treatment for Influenza or Allergies.

For oral use only.

Each bottle contains at least 90 sprays = 45 doses. Adulls and Children 12 years and over:
• for best results, begin treatment at start of symptoms (within 24-48 hours of onset)
• spray 2 times in mouth at the onset of symptoms on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.
• repeat every 2-4 hours as needed until all symptoms subside. Up to 12 sprays (6 doses) per day. For Children under 12 years of age, consult a heallhcare practitioner prior to use.

Inactive ingredients: benzalkonium chloride, glycerine, glycine, maleic acid, natural flavors, sucralose and water

Other Information
• avoid possible minor stomach upset - do not take on an empty stomach
• do not eat or drink for 15 minutes after use
• avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking Cold-EEZE Oral Spray as it may diminish product  effectiveness, otherwise, drink plenty of fluids
• store in a cool dry place after opening
• no artificial colors

Label
Unit Carton

COLD-EEZE MINT 
zink gluconate glycine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0127
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC GLUCONATE (ZINC) ZINC GLUCONATE2 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
MALEIC ACID 
GLYCINE 
BENZALKONIUM CHLORIDE 
PROPYLENE GLYCOL 
ACACIA 
ALCOHOL 
ASCORBIC ACID 
SODIUM HYDROXIDE 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:61941-0127-224 CARTON ( CARTON) in 1 CASEcontains a CARTON (61941-0127-6)
1NDC:61941-0127-61 BOTTLE, SPRAY ( BOTTLE) in 1 CARTONThis package is contained within the CASE (61941-0127-2) and contains a BOTTLE, SPRAY
122.5 mL in 1 BOTTLE, SPRAYThis package is contained within a CARTON (61941-0127-6) and a CASE (61941-0127-2)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/01/2011

Labeler - ProPhase Labs, Inc. (620557298)
Registrant - Ei Inc. (105803274)
Establishment
NameAddressID/FEIOperations
Ei Inc.105803274manufacture, label, relabel, pack, repack

Revised: 10/2011 ProPhase Labs, Inc.