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NDC 51393-7588-04 Migraine 30; 30 [hp_X]/100mL; [hp_C]/100mL Details

Migraine 30; 30 [hp_X]/100mL; [hp_C]/100mL

Migraine is a TOPICAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Forces of Nature. The primary component is IRIS VERSICOLOR ROOT; SODIUM CHLORIDE.

Product Information

NDC	51393-7588
Product ID	51393-7588_0e50403b-de8a-4788-af58-5b123cf7df96
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Migraine
Proprietary Name Suffix	Pain Management
Non-Proprietary Name	Iris Versicolor Root and Sodium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	TOPICAL
Active Ingredient Strength	30; 30
Active Ingredient Units	[hp_X]/100mL; [hp_C]/100mL
Substance Name	IRIS VERSICOLOR ROOT; SODIUM CHLORIDE
Labeler Name	Forces of Nature
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51393-7588-04 (51393758804)

Pricing Information	N/A
NDC Package Code	51393-7588-4
Billing NDC	51393758804
Package	4 mL in 1 BOTTLE, DISPENSING (51393-7588-4)
Marketing Start Date	2016-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2d3faa4f-c0a0-4989-8fa6-689d0382e123 Details

SPL UNCLASSIFIED SECTION

CONTROL DRUG FACTS

Active Ingredients

Iris Versicolor130C - Relieves chronic headaches and shooting pain

Natrum Muriaticum130C - Relieves pain due to migraines

1: Certified Organic

Also Contains

Sesame Oil1, Lavandin Oil1, Roman Chamomile Oil1, Rosemary Oil1

Indications

For the temporary relief of migraine headaches.

Directions

Apply to temples and back of the neck as needed, gently rub into skin. For children under 2 years of age, consult a doctor first.

Warnings

Some individuals may be sensitive to essential oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin.

For external use only. If accidental ingestion of more than several drops, and adverse reaction occurs, get medical help or contact a Poison Control Center. Do not apply to the eyes. If you are pregnant or breast - feeding, ask a health professional before use. Not for use on children under the age of 3.

Keep all medicines out of the reach of children.

Stop use and consult a doctor if condition worsens, or consult a doctor if symptoms show no improvement after 7 days.

SPL UNCLASSIFIED SECTION

Manufactured & Distributed by

FORCES OF NATURE®

21787 8th St East #3A Sonoma, CA 95476 USA

PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton

ORGANIC

NDC #51393-7588-4

FORCES OF NATURE®

CERTIFIED ORGANIC MEDICINESM

Migraine

ROLLERBALL APPLICATOR

Topical Migraine Medicine

Rapid Relief for

Acute Migraine Pain
Deep Penetrating Action
All Natural Analgesic
Rare Essential Oils

by Elite Growers

from Across

the Planet

Iris

Versicolor

.14 OZ/4 ml Rollerball

Principal Display Panel - 4 ml Bottle Carton

INGREDIENTS AND APPEARANCE

MIGRAINE PAIN MANAGEMENT

iris versicolor root and sodium chloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51393-7588
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC)	Iris Versicolor Root	30 [hp_X] in 100 mL
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Chloride	30 [hp_C] in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Chamaemelum Nobile Flower Oil (UNII: UB27587839)
Lavandin Oil (UNII: 9RES347CKG)
Rosemary Oil (UNII: 8LGU7VM393)
Sesame Oil (UNII: QX10HYY4QV)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51393-7588-1	11 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	12/01/2011
2	NDC:51393-7588-2	33 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	12/01/2011
3	NDC:51393-7588-4	4 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED HOMEOPATHIC		12/01/2011

Labeler - Forces of Nature (050169130)

Revised: 4/2020

Document Id: 0e50403b-de8a-4788-af58-5b123cf7df96

Set id: 2d3faa4f-c0a0-4989-8fa6-689d0382e123

Version: 4

Effective Time: 20200427

Search by Drug Name or NDC

NDC 51393-7588-04 Migraine 30; 30 [hp_X]/100mL; [hp_C]/100mL Details

Migraine 30; 30 [hp_X]/100mL; [hp_C]/100mL

Product Information

Package

Package Images

NDC 51393-7588-04 (51393758804)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2d3faa4f-c0a0-4989-8fa6-689d0382e123 Details

SPL UNCLASSIFIED SECTION

Active Ingredients

Also Contains

Indications

Directions

Warnings

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton

INGREDIENTS AND APPEARANCE

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