1. Home
  2. Labeler Index
  3. Troy Manufacturing, Inc.
  4. 63936-9700
  5. Label Information: Stopain Clinical Migraine And Headache

FDA Label for Stopain Clinical Migraine And Headache

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF
    6. KEEP OUT OF REACH OF CHILDREN.
    7. STOP USE AND CONSULT A DOCTOR IF
    8. IF PREGNANT OR BREAST FEEDING
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS:
    11. PACKAGE LABELING:

Stopain Clinical Migraine And Headache Product Label

The following document was submitted to the FDA by the labeler of this product Troy Manufacturing, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


Package Labeling:



Label - Label

Label - Label


* Please review the disclaimer below.