NativeRemedies® XY Health Pro™ Oral Spray

XY Health Pro by

Drug Labeling and Warnings

XY Health Pro by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, King Bio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

XY HEALTH PRO- agnus, conium, lycopodium, sabal, sulphur spray 
Silver Star Brands

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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NativeRemedies® XY Health Pro™ Oral Spray

HPUS Active Ingredients:

Equal volumes of each ingredient in a 30C potency: Agnus, Conium, Lycopodium, Sabal, Sulphur.

Uses*:

Homeopathic remedy to support male sexual health.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings:

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children, In case of overdose, get medical help or contact a Poison Control Cente right away.

Directions:

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily until symptoms improve. Adults: 3 pump sprays.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com. Contains no artificial flavors or colorants. No gluten added.

Inactive Ingredients:

Citric acid, potassium sorbate, purified water.

Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breastfeeding, ask a health professional before use.

Supports male sexual health

XY HEALTH PRO 
agnus, conium, lycopodium, sabal, sulphur spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-288
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A)	CHASTE TREE	30 [hp_C]  in 59 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	30 [hp_C]  in 59 mL
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	30 [hp_C]  in 59 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_C]  in 59 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_C]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-288-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/24/2017	02/11/2020

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	api manufacture(68703-288) , manufacture(68703-288)

Revised: 2/2020

Document Id: 9e5244fc-ef62-3ac3-e053-2a95a90ae105

34390-5

Set id: 4d11cc46-394c-1561-e054-00144ff8d46c

Version: 2

Effective Time: 20200211

 

Silver Star Brands