ReBoost by MediNatura ReBoost Nasal Spray

ReBoost by

Drug Labeling and Warnings

ReBoost by is a Homeopathic medication manufactured, distributed, or labeled by MediNatura. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REBOOST- silver nitrate,euphorbia resinifera resin, calcium sulfide, goldenseal, potassium dichromate,luffa operculata fruit, sodium carbonate, and pulsatilla vulgaris spray 
MediNatura

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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ReBoost Nasal Spray

ACTIVE INGREDIENTS

Each 20ml contains

Active Ingredients                        Purpose

Argentum nitricum10X................Relieves nasal itching

*Euphorbium officinarum 4X........Relieves sneezing

Hepar sulphuris calcareum 10X....Relieves runny nose

*Hydrastis canadensis 3X............Relieves sinus headache & pressure

Kali bichromicum 6X....................Relieves nasal congestion

*Luffa operculata 2X...................Relieves nasal congestion

Natrum carbonicum 6X...............Relieves sneezing and runny nose

*Pulsatilla 2X..............................Relieves nasal congestion

*Natural Ingredients

PURPOSE

Relieves

Nasal Congestion

Sinus Headache & Pressure

Cold/Flu Nasal Symptoms

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Uses

For the temporary relief of minor nasal symptoms:Nasal Congestion Sinus Headache and Pressure Cold/Flu Nasal Symptoms

WARNINGS

Warnings: Ask a doctor before use if you have asthma. In rare cases bronchospasm may occur in asthmatic patients. Temporary burning, stinging, sneezing, or increased nasal discharge may occur. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. The use of this dispenser by more than one person may spread infection. If symptoms persist or worsen, a health professional should be consulted. Do not use if known sensitivity to ReBoost™ or any of its ingredients exists.

DIRECTIONS

At first sign of symptoms: Adults and children12 years and older: 2 sprays into each nostril every ½ to 1 hour, until symptoms lessen, then continue with standard dosage. Do not exceed 48 sprays in 24 hours.

Children 4 to 11 years: 1 spray into each nostril every ½ to 1 hour until symptoms lessen, then continue with standard dosage.

Do not exceed 24 sprays in 24 hours.

For children under 4 years, consult your health professional.

Standard Dosage:Adults and children 12 years and older: 2 sprays into each nostril every 4 to 6 hours. Children 4 to 11 years: 1 spray into each nostril every 4 to 6 hours. For children under 4 years, consult your health professional.

INACTIVE INGREDIENTS

Benzalkonium chloride 0.02%, Disodium phosphate dihydrate, Isotonic sodium chloride solution, and Sodium dihydrogen phosphate dihydrate

REBOOST 
silver nitrate,euphorbia resinifera resin, calcium sulfide, goldenseal, potassium dichromate,luffa operculata fruit, sodium carbonate, and pulsatilla vulgaris spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62795-4001
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	10 [hp_X]  in 20 mL
EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K)	EUPHORBIA RESINIFERA RESIN	4 [hp_X]  in 20 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	10 [hp_X]  in 20 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X]  in 20 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	6 [hp_X]  in 20 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	2 [hp_X]  in 20 mL
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D)	SODIUM CARBONATE	6 [hp_X]  in 20 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	2 [hp_X]  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62795-4001-9	1 in 1 CARTON	01/31/2018	02/07/2020
1		20 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/30/2014	02/07/2020

Labeler - MediNatura (079324099)

Establishment
Name	Address	ID/FEI	Business Operations
MediNatura		102783016	manufacture(62795-4001)

Revised: 2/2020

Document Id: 047c9e60-226b-4c9c-aed7-38a48ca32172

34390-5

Set id: 8b73a887-faea-4470-91fe-22cf598fef3f

Version: 4

Effective Time: 20200210

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