STOPAIN CLINICAL MIGRAINE AND HEADACHE- menthol, unspecified form, atropa belladonna, iris versicolor root, sanguinaria canadensis root gel

STOPAIN CLINICAL Migraine and Headache by

Drug Labeling and Warnings

STOPAIN CLINICAL Migraine and Headache by is a Homeopathic medication manufactured, distributed, or labeled by Troy Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Mentholum 1X HPUS-60.00%

Belladonna 3X HPUS-1.33%

Iris Versicolor 6X HPUS-1.33%

Sanguinaria Canadensis 6X HPUS-1.33%

Purpose

Frontal Headache

Temple/Occiput Pain

Sick Headache

Back of Head Pain

Uses

Temporarily relieves head pain associated with migraine and headache.

Warnings

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 healthcare professional before using this product topically on children 2-12 years of age.

Avoid contact with eyes. If gel gets in eyes or on muscus membranes flush with cool water for 1-2 minutes

Ask a doctor before use if

you have never had migraines diagnosed by a health professional

Do not apply to broken or irritated skin

Do not apply to forehead or temples

Keep out of reach of children.

If swallowed, get medicial help or contact a Poison Control Center.

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

If pregnant or breast feeding

ask a health professional before use.

Directions

 Adults and children over 12 years: Tear open packe  Dispense product onto finger tips  Apply to back of neck and behind each ear until product is absorbed   Use entire contents of packet  For best results, apply as soon as you feel discomfort  If after 30 minutes the symptoms persist, apply second packet

Inactive Ingredients:

Acrylic acid/vinyl ester copolymer, ethanol (USP), hydroxypropylcellulose, pentylene glycol, triethanolamine, water (USP)

SPL UNCLASSIFIED SECTION

Store at room temperature.

SPL UNCLASSIFIED SECTION

Manufactured for Troy Healthcare, LLC 130 Lions Drive Hazleton, PA 18202 (800) 201-7246 stopainclinical.com

Package Labeling:

INGREDIENTS AND APPEARANCE

STOPAIN CLINICAL MIGRAINE AND HEADACHE 
menthol, unspecified form, atropa belladonna, iris versicolor root, sanguinaria canadensis root gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63936-9700
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 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_X]  in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	3 [hp_X]  in 1 g
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	6 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63936-9700-1	12 in 1 BOX	07/01/2018
1		1 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2018

Labeler - Troy Manufacturing, Inc. (160075248)

Registrant - Troy Manufacturing, Inc. (160075248)

Establishment
Name	Address	ID/FEI	Business Operations
Troy Manufacturing, Inc.		160075248	manufacture(63936-9700)