Stopain Clinical Migraine & Headache

Stopain Clinical Migraine & Headache
SPL v3
SPL
SPL Set ID c5b690ce-7bb6-4840-b00b-205cd5bc6be6
Route
TOPICAL
Published
Effective Date 2023-01-25
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
Hydroxypropyl Cellulose, Unspecified Pentylene Glycol Trolamine Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-07-01

Description

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


Medication Information

Purpose

Frontal Headache

Temple/Occiput Pain

Sick Headache

Back of Head Pain

Description

Mentholum 1X HPUS-60.00% Belladonna 3X HPUS-1.33% Iris Versicolor 6X HPUS-1.33% Sanguinaria Canadensis 6X HPUS-1.33%

Uses

Temporarily relieves head pain associated with migraine and headache.

Section 42229-5

Store at room temperature.

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

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

Active Ingredients

Mentholum 1X HPUS-60.00%

Belladonna 3X HPUS-1.33%

Iris Versicolor 6X HPUS-1.33%

Sanguinaria Canadensis 6X HPUS-1.33%

Inactive Ingredients:

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

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

If Pregnant Or Breast Feeding

ask a health professional before use.

Package Labeling:63936 9700 1

Keep Out of Reach of Children.

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

Package Labeling: 63936 9700 2

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


Structured Label Content

Uses

Temporarily relieves head pain associated with migraine and headache.

Section 42229-5 (42229-5)

Store at room temperature.

Purpose

Frontal Headache

Temple/Occiput Pain

Sick Headache

Back of Head Pain

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

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

Active Ingredients

Mentholum 1X HPUS-60.00%

Belladonna 3X HPUS-1.33%

Iris Versicolor 6X HPUS-1.33%

Sanguinaria Canadensis 6X HPUS-1.33%

Inactive Ingredients:

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

Ask A Doctor Before Use If (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

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a health professional before use.

Package Labeling:63936 9700 1 (Package Labeling:63936-9700-1)

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

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

Package Labeling: 63936 9700 2 (Package Labeling: 63936-9700-2)

Stop Use and Consult A Doctor If (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


Advanced Ingredient Data


Raw Label Data

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