Label: PREVENCIA- fucus vesiculosus, bovine colostrum spray
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Contains inactivated NDC Code(s)
NDC Code(s): 82506-100-15 - Packager: Core Consumer Healthcare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated October 11, 2022
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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 occurStop 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 occurIf 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 occurStop 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 occurIf 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.
- Prevencia Nasal Spray
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INGREDIENTS AND APPEARANCE
PREVENCIA
fucus vesiculosus, bovine colostrum sprayProduct 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)
