STOPAIN MIGRAINE PAIN RELIEVING- mentholum, belladonna, iris versicolor, sanguinaria canadensis gel

Stopain Migraine Pain Relieving by

Drug Labeling and Warnings

Stopain Migraine Pain Relieving by is a Homeopathic medication manufactured, distributed, or labeled by TROY MANUFACTURING, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Mentholum 1X HPUS-50.00%

Belladonna 3X HPUS-1.33%

Iris Versicolor 6X HPUS-1.33%

Sanguinaria Canadensis 6X HPUS-1.33%

Purpose

migraine pain

migraine pain

migraine pain

migraine pain

Uses

Temporarily relieves head pain associated with migraine.

Warnings

Do not apply to broken or irritated skin

Do not apply to forehead or temples

Ask a doctor before use iif you have

never had migraines diadnosed by a health professional

For external use only.

This product should not be used topically on children younger than 2 years of age, nor should it be applied on any mucus membranes of any age child or adult. Seek the advice of your health care professional before using this product topically on children 2 to 12 years of age.

Avoid contact with eyes.

If gel gets into eyes or on mucus membranes flush with cool water for 1-2 minutes.

If pregnant or breast feeding

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and consult a doctor if

• condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days.
• redness is present.
• excessive irritation of the skin occurs.

Directions

Adults and children over 12 years

• Remove cap For first application press down several times to prime actuator pump for use
• After actuator has been primed press and release pump once to dispense gel onto finger tips
• Apply to one side on back of neck and behind the ear, repeat for the other side, applying a single pump of product for each side
• For best results, apply as soon as you feel discomfort
• If after 30 minutes the symptoms still persist, reapply as needed, up to 4 times daily
• See insert for more details

Inactive Ingredients

Carbopol polymer, ethanol (USP), pentylene glycol, silicone dioxide, triethanolamine, water (USP)

STORAGE AND HANDLING

Store at room temperature.

SPL UNCLASSIFIED SECTION

Manufactured for: Troy Healthcare, LLC 130 Lions Drive, Hazleton, PA 18202

800-201-PAIN (7246)

www.stopain.com

Product labeling

Stopain

MIGRAINE

TOPICAL

PAIN RELIEVING

GEL

MENTOLUM, BELLADONNA,

IRIS VERSICOLOR,

AND SANGUINARIA CANADENSIS.

For external use only

HOMEOPATHIC

1.62 FL OZ (50mL)

100 pumps

Claims based upon traditional homeopathic support.

Does not contain:

Acetaminophen

Aspirin

Caffeine

For best results:

Apply as soon as you feel discomfort.

If after 30 minutes the symptoms persist, apply as needed, up to 4 times daily.

No know drug interactions

Features and Benefits:

Fast Relief

Safe & Effective

Precision Dosing System

Package Label

INGREDIENTS AND APPEARANCE

STOPAIN MIGRAINE PAIN RELIEVING 
mentholum, belladonna, iris versicolor, sanguinaria canadensis gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63936-8700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 [hp_X]  in 50 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_X]  in 50 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	6 [hp_X]  in 50 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	6 [hp_X]  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63936-8700-1	1 in 1 CARTON	03/20/2015
1		50 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		03/20/2015

Labeler - TROY MANUFACTURING, INC (160075248)

Registrant - TROY MANUFACTURING, INC (160075248)

Establishment
Name	Address	ID/FEI	Business Operations
TROY MANUFACTURING, INC		160075248	manufacture(63936-8700)