NativeRemedies® Boil Soothe™ Oral Spray

Boil Soothe by

Drug Labeling and Warnings

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

Drug Details [pdf]

BOIL SOOTHE- arnica, calc sulph, hepar sulph calc, merc solub, silicea 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® Boil Soothe™ Oral Spray

HPUS Active Ingredients

Equal volumes of each ingredient: Arnica 30C, Calc sulph 6X, Hepar sulph calc 30C, Merc solub 30C, Silicea 6X.

Uses*:

Temporarily relieves minor pain and discomfort associated with boils.

*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 Center right away.

Directions:

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3-6 times daily during the first day and 3 times daily thereafter, or until symptoms improve. Adults and children 12+: Take 2-3 pump sprays. Children under 12: Take 1-2 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.

Temporarily relieves minor pain & discomfort associated with boils

BOIL SOOTHE 
arnica, calc sulph, hepar sulph calc, merc solub, silicea spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-269
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM SULFATE (UNII: WAT0DDB505) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFATE	6 [hp_X]  in 59 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	30 [hp_C]  in 59 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_C]  in 59 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	30 [hp_C]  in 59 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	6 [hp_X]  in 59 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-269-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/21/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/21/2016	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(68703-269) , manufacture(68703-269)

Revised: 2/2020

Document Id: 9e52517b-3cdd-646c-e053-2a95a90aabde

34390-5

Set id: 4186254d-af75-2697-e054-00144ff88e88

Version: 2

Effective Time: 20200211

 

Silver Star Brands