COLD AND INFECTION DEFENSE- nasal throat spray liquid
Vitality Works, 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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Cold and Infection Defense

Echinacea purpurea 4X

Belladonna 5X

Cold and Infection Defense

USP Purified Water, Collodial Silver 15 ppm, Xylitol, Sodium Chloride, Grapefruit Seed Extract, Sodium Hydroxide

Cold and Infection Defense

If pregnant or nursing, seek advice from a health care professional. Not for use by more that 1 person. For safety finish the bottle within 60 days after opening. Keep out of reach of children.

Cold and Infection Defense

Keep out of reach of children.

Cold and Infection Defense

Temporary relief of symptoms associated with common cold, flu, sinusitis and sore throat.

Cold and Infection Defense

Kee head upright, spray 1-3 times in each nostril and/or throat. Repeat 1-4 times per day as needed.

Cold and Infection Defense

Temporary relief of syptoms associated with common cold, flu, sinusitis, and sore throat.

Cold and Infection Defense

Cold & Infection Defense

COLD AND INFECTION DEFENSE
nasal throat spray liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64616-041
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	4 [hp_X] in 1 mL
ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU) (ECHINACEA PURPUREA ROOT - UNII:OS64WTR4KU)	ECHINACEA PURPUREA ROOT	4 [hp_X] in 1 mL
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI)	BELLADONNA LEAF	5 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SILVER (UNII: 3M4G523W1G)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64616-041-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/16/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/16/2003

Labeler - Vitality Works, Inc (137752817)

Registrant - Vitality Works, Inc (137752817)

Name	Address	ID/FEI	Business Operations
Establishment
Vitality Works, Inc		137752817	manufacture(64616-041)