Stopain Migraine Topical Pain Relieving Gel

Stopain Migraine Topical Pain Relieving Gel
SPL v7
SPL
SPL Set ID 5641c17f-bf3f-48a5-a3a8-c80d381c17a4
Route
TOPICAL
Published
Effective Date 2021-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 [hp_X]) Atropa Belladonna (3 [hp_X]) Iris Versicolor Root (6 [hp_X]) Sanguinaria Canadensis Root
Inactive Ingredients
Alcohol Pentylene Glycol Silicon Dioxide Trolamine Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-03-20

Description

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


Medication Information

Purpose

Migraine Pain

Description

Mentholum 1X HPUS-50.00% Belladonna 3X HPUS-1.33% Iris Versicolor 6X HPUS-1.33% Sanguinaria Canadensis 6X HPUS-1.33%

Uses

Provides temporary relief from migraine symptoms such as:

  • Headaches
  • Sensitivity to light
  • nausea
Warnings

For external use only. Avoid contact with eyes.

Flammable: Keep away from fire or flame

Directions

Adults and children over 12 years:

Remove cap. For the initial use, press down several times to prime the actuator pump. After priming, press and release the pump once to dispense gel onto your fingertips. Apply the gel to one side of the back of your neck and behind your ear, then repeat on the other side, using one pump for each application. For optimal results, apply as soon as you experience discomfort. If symptoms persist after 30 minutes, you may reapply as needed, up to 4 times a day. Children under 12 years of age: do not use; consult a doctor.

Other Information

Store at room temperature.

Package Labeling:

Active Ingredients

Mentholum 1X HPUS-50.00%

Belladonna 3X HPUS-1.33%

Iris Versicolor 6X HPUS-1.33%

Sanguinaria Canadensis 6X HPUS-1.33%

Inactive Ingredients

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

When Using This Product
  • use only as directed
  • do not bandage tightly or use a heating pad
  • do not apply to the forehead or temples
  • do not apply to wounds or damaged skin
Stop 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 or excessive irritation occurs
If Pregnant Or Breast Feeding,

ask a healthcare professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

Provides temporary relief from migraine symptoms such as:

  • Headaches
  • Sensitivity to light
  • nausea
Purpose

Migraine Pain

Warnings

For external use only. Avoid contact with eyes.

Flammable: Keep away from fire or flame

Directions

Adults and children over 12 years:

Remove cap. For the initial use, press down several times to prime the actuator pump. After priming, press and release the pump once to dispense gel onto your fingertips. Apply the gel to one side of the back of your neck and behind your ear, then repeat on the other side, using one pump for each application. For optimal results, apply as soon as you experience discomfort. If symptoms persist after 30 minutes, you may reapply as needed, up to 4 times a day. Children under 12 years of age: do not use; consult a doctor.

Other Information

Store at room temperature.

Package Labeling:

Active Ingredients

Mentholum 1X HPUS-50.00%

Belladonna 3X HPUS-1.33%

Iris Versicolor 6X HPUS-1.33%

Sanguinaria Canadensis 6X HPUS-1.33%

Inactive Ingredients

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

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly or use a heating pad
  • do not apply to the forehead or temples
  • do not apply to wounds or damaged skin
Stop and Consult A Doctor If (Stop 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 or excessive irritation occurs
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a healthcare professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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