PREVENCIA- fucus vesiculosus, bovine colostrum spray

PREVENCIA by

Drug Labeling and Warnings

PREVENCIA by is a Homeopathic medication manufactured, distributed, or labeled by Core Consumer Healthcare LLC, Dennis O'Donnell. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Labeling

Drug Facts

Active ingredients Purpose

Fucus vesiculosus (Fucoidan) HPUS 3X Natural antiviral

Colostrum sarcodes HPUS 3X Natural antiviral

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

Warnings

For nasal use only

Do not use if you have a sensitivity or allergy to any of the ingredients. If an allergic reaction occurs, stop use and ­­­seek medical help right away.

Ask a doctor before use if you have ear, nose, or throat sensitivity or susceptibility to nosebleeds.

When using this product

if accidental eye contact, skin irritation, or rash occurs, rinse with water and discontinue use
use of this container by more than one person may spread infection
temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

Stop use and ask a doctor if

symptoms get worse or last more than 7 days or accompanied by fever
redness or swelling is present * new symptoms occur

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Directions

Adults and children 12 years of age and older:

Shake well before using. Remove cap and clip. Before using for the first time, prime pump by depressing the rim a few times for the fine mist to appear.
Without tilting head, place tip of nozzle in the nostril. Without inhaling, depress the rim and pump once into each nostril. Do not overspray.
Wipe away any excess.
Use every 4 to 6 hours.

Other information * store at room temperature 15-29° (59-84°F)

Inactive ingredients aloe vera, benzalkonium chloride, carboxymethylcellulose sodium, cetrimonium chloride, deionized water, menthol, polyquaternium-22, potassium sorbate, propylene glycol, sodium phosphate, and xanthan gum.

Directions for Use

Directions

Adults and children 12 years of age and older:

Shake well before using. Remove cap and clip. Before using for the first time, prime pump by depressing the rim a few times for the fine mist to appear.
Without tilting head, place tip of nozzle in the nostril. Without inhaling, depress the rim and pump once into each nostril. Do not overspray.
Wipe away any excess.
Use every 4 to 6 hours.

Warnings

Warnings

For nasal use only

Do not use if you have a sensitivity or allergy to any of the ingredients. If an allergic reaction occurs, stop use and ­­­seek medical help right away.

Ask a doctor before use if you have ear, nose, or throat sensitivity or susceptibility to nosebleeds.

When using this product

if accidental eye contact, skin irritation, or rash occurs, rinse with water and discontinue use
use of this container by more than one person may spread infection
temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

Stop use and ask a doctor if

symptoms get worse or last more than 7 days or accompanied by fever
redness or swelling is present * new symptoms occur

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Inactive Ingredients

Inactive ingredients aloe vera, benzalkonium chloride, carboxymethylcellulose sodium, cetrimonium chloride, deionized water, menthol, polyquaternium-22, potassium sorbate, propylene glycol, sodium phosphate, and xanthan gum.

Indications and Usage

Use to reduce risk of cold and flu infections

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

OTC Purpose

Reduce risk of cold and flu infections

Prevencia Nasal Spray

INGREDIENTS AND APPEARANCE

PREVENCIA 
fucus vesiculosus, bovine colostrum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82506-100
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	0.015 mg  in 15 mL
BOS TAURUS COLOSTRUM (UNII: S256WJ3OFQ) (BOS TAURUS COLOSTRUM - UNII:S256WJ3OFQ)	BOS TAURUS COLOSTRUM	0.015 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)	0.15 mL  in 15 mL

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82506-100-15	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/17/2022

Labeler - Core Consumer Healthcare LLC (130851598)

Registrant - Dennis O'Donnell (130851598)