NativeRemedies® FlowCalm™ Oral Spray

FlowCalm by

Drug Labeling and Warnings

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

Drug Details [pdf]

FLOWCALM- caulophyllum thalictroides, cimicifuga racemosa, ipecacuanha, sepia, vinca minor 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® FlowCalm™ Oral Spray

HPUS Active Ingredients:

Equal volumes of each ingredient: Caulophyllum, thalictroides 6C, Cimicifuga racemosa 30C, Ipecacuanha 6C, Sepia 30C, Vinca minor 6C.

Uses*:

Homeopathic remedy to support healthy menstrual bleeding.

*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 times daily until symptoms improve. Adults and children 12+: 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 healthy menstrual bleeding

FlowCalm

FLOWCALM 
caulophyllum thalictroides, cimicifuga racemosa, ipecacuanha, sepia, vinca minor spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68703-296
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH30 [hp_C]  in 59 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC6 [hp_C]  in 59 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_C]  in 59 mL
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT6 [hp_C]  in 59 mL
VINCA MINOR (UNII: WGM46PQF02) (VINCA MINOR - UNII:WGM46PQF02) VINCA MINOR6 [hp_C]  in 59 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68703-296-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/17/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/17/201702/11/2020
Labeler - Silver Star Brands (006070379)
Registrant - Silver Star Brands (006070379)
Establishment
NameAddressID/FEIBusiness Operations
King Bio617901350api manufacture(68703-296) , manufacture(68703-296)

Revised: 2/2020
Document Id: 9e527f23-049b-db91-e053-2a95a90a8d40
Set id: 4d11a65e-696c-0727-e054-00144ff88e88
Version: 2
Effective Time: 20200211
 
Silver Star Brands