Healthful™ Naturals Goutcalm - 59 Ml

Healthful™ Naturals Goutcalm - 59 Ml
SPL v2
SPL
SPL Set ID 82e2da70-804e-eebd-e053-2a91aa0aff5b
Route
TOPICAL
Published
Effective Date 2019-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Antimony Trisulfide (6 [hp_C]) Berberis Vulgaris Fruit (30 [hp_C]) Lithium Cation
Inactive Ingredients
Black Pepper Oil Grape Seed Oil Basil Oil Celery Seed Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-14

Description

HPUS* Active ingredients - Equal volumes of each ingredient as follows: Antimonium crudum (6C), Berberis vulgaris (30C), Lithium carbonicum (6C). *"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.


Medication Information

Description

HPUS* Active ingredients - Equal volumes of each ingredient as follows: Antimonium crudum (6C), Berberis vulgaris (30C), Lithium carbonicum (6C). *"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses+:

Uses+: For symptomatic treatment of gout joint pain and inflammation.

+ As per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

Section 50565-1

Keep out of reach of children.

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health care professional before use.

Section 55105-1

HPUS* Active ingredients Purpose+

Equal volumes of each ingredient as follows:

Antimonium crudum (6C)..................................Stiffness, swelling

Berberis vulgaris (30C).....................................Burning pain

Lithium carbonicum (6C)..................................Joint pain

Section 60561-8

Other information:

Intended to complement, not replace, standard medical care.

Tamper resistant for your protection. Use only if safety seal is intact.

Warnings

Warnings: If symptoms persist or worsen, discontinue use immediately and consult a healthcare professional.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

For external use only.

Avoid using near eyes or mouth.

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

Some individuals may be sensitive to essential oils. If irritation or reaction occurs, discontinue use.

Directions

Directions: Shake well before using.

Spray onto entire affected area and massage into skin every 2 hours until pain begins to subside.

Adults and children over 12 years of age.

Inactive Ingredients

Inactive ingredients: Basil essential oil, black pepper essential oil, celery essential oil, grapeseed oil.

Hpus* Active Ingredients

HPUS* Active ingredients - Equal volumes of each ingredient as follows: Antimonium crudum (6C), Berberis vulgaris (30C), Lithium carbonicum (6C).

*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.


Structured Label Content

Uses+:

Uses+: For symptomatic treatment of gout joint pain and inflammation.

+ As per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health care professional before use.

Section 55105-1 (55105-1)

HPUS* Active ingredients Purpose+

Equal volumes of each ingredient as follows:

Antimonium crudum (6C)..................................Stiffness, swelling

Berberis vulgaris (30C).....................................Burning pain

Lithium carbonicum (6C)..................................Joint pain

Section 60561-8 (60561-8)

Other information:

Intended to complement, not replace, standard medical care.

Tamper resistant for your protection. Use only if safety seal is intact.

Warnings

Warnings: If symptoms persist or worsen, discontinue use immediately and consult a healthcare professional.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

For external use only.

Avoid using near eyes or mouth.

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

Some individuals may be sensitive to essential oils. If irritation or reaction occurs, discontinue use.

Directions

Directions: Shake well before using.

Spray onto entire affected area and massage into skin every 2 hours until pain begins to subside.

Adults and children over 12 years of age.

Inactive Ingredients (Inactive ingredients)

Inactive ingredients: Basil essential oil, black pepper essential oil, celery essential oil, grapeseed oil.

Hpus* Active Ingredients (HPUS* Active ingredients)

HPUS* Active ingredients - Equal volumes of each ingredient as follows: Antimonium crudum (6C), Berberis vulgaris (30C), Lithium carbonicum (6C).

*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.


Advanced Ingredient Data


Raw Label Data

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