Pain Relief

Pain Relief
SPL v7
SPL
SPL Set ID 480dc24e-87d0-55db-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Flower (1 [hp_X])
Inactive Ingredients
Olive Oil Yellow Wax Sunflower Oil Menthol Rosemary Oil Cinnamon Oil Ginger Oil Mentha Piperita

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-03-31

Description

External Analgesic

Purpose

External Analgesic

Storage and Handling

Store at room temperature.


Medication Information

Purpose

External Analgesic

Storage and Handling

Store at room temperature.

Description

External Analgesic

Warnings

Warnings

For external use only.

■ Avoid contact with eyes.

■ Do not use on ■ on deep wounds ■ animal bites ■ serious burns

■ Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days

Indications & Usage

■ temporarily reief of minor aches and pains of muscles and joints associated with ■ arthritis ■ bruises ■ sprains ■ scrapes ■ strains ■ simple backache ■ sore muscles

Inactive Ingredients

Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax), Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Menthol, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Zingiber Officinale (Ginger) Root Oil, Cinnamomum Zeylanicum Bark (Cinnamon) Oil.

Otc Active Ingredients

Organic Arnica montana (Arnica) 1X (HPUS)

Dosage & Administration

Adults and children 2 years of age and older: Apply to affected area

not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Principal Display Panel

Keep Out of Reach of Children

Keep Out of Reach of Children.


Structured Label Content

Purpose

External Analgesic

Warnings

Warnings

For external use only.

■ Avoid contact with eyes.

■ Do not use on ■ on deep wounds ■ animal bites ■ serious burns

■ Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days

Indications & Usage

■ temporarily reief of minor aches and pains of muscles and joints associated with ■ arthritis ■ bruises ■ sprains ■ scrapes ■ strains ■ simple backache ■ sore muscles

Inactive Ingredients

Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax), Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Menthol, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Zingiber Officinale (Ginger) Root Oil, Cinnamomum Zeylanicum Bark (Cinnamon) Oil.

Storage and Handling

Store at room temperature.

Otc Active Ingredients (OTC Active Ingredients)

Organic Arnica montana (Arnica) 1X (HPUS)

Dosage & Administration

Adults and children 2 years of age and older: Apply to affected area

not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Principal Display Panel

Keep Out of Reach of Children

Keep Out of Reach of Children.


Advanced Ingredient Data


Raw Label Data

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