Free To Breathe

Free To Breathe
SPL v8
SPL
SPL Set ID 8d437d62-2cbc-5b17-e053-2a95a90ad5cb
Route
TOPICAL
Published
Effective Date 2020-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flower (1 [hp_X]) Eucalyptus Globulus Leaf (1.63 g) Mentha Piperita
Inactive Ingredients
Sunflower Oil Lavender Oil Cryptocarya Agathophylla Leaf Oil Olive Oil Alpha-tocopherol Rosemary Oil Yellow Wax Castor Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-03-06

Description

Skin Protectant Cough Suppressant Topical Analgesic

Purpose

Skin Protectant Cough Suppressant Topical Analgesic

Storage and Handling

Store at room temperature.


Medication Information

Purpose

Skin Protectant

Cough Suppressant

Topical Analgesic

Storage and Handling

Store at room temperature.

Description

Skin Protectant Cough Suppressant Topical Analgesic

Warnings

Warnings

For external use only.

Do not use on ■ on deep wounds ■ serious burns ■ by mouth ■ in nostrils ■ with tight bandages ■ with heat ■ in a vaporizor

Avoid contact with eyes. Rinse with water to remove eyes. Rinse with water to remove.

Stop use and ask a doctor if you ■ nasal congestion gets worse ■ condition worsens ■ symptoms last more than 7 days or clears up and occurs again within a few days

Ask Doctore before use if you ■ have cough with excessive mucus ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ if pregnant or breast-feeding ■ children under 2 years

Indications & Usage

■ helps prevent and temporarily protects and helps relieve ■ chapped or cracked skin

■ when applied to the chest, throat, and bottom of feet, temporarily relieves cough due to minor throat and bronchial irritation associated with a cold

■ temporarily relieves minor aches and pains of muscles and joints

Inactive Ingredients

Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax), Organic Ricinus Communis (Castor) Seed Oil, Organic Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Agathophyllum Aromatica (Ravensara) Leaf Oil.

Otc Active Ingredients

Organic Calendula Officinalis (Calendula) Flower Oil

Eucalyptus Globulus (Eucalyptus) Oil

Mentha Piperita (Peppermint) Oil

Dosage & Administration

Rub gently on chest, neck or bottom of the feet. Apply 2-3 times a day.

Principal Display Panel

Keep Out of Reach of Children

Keep Out of Reach of Children.


Structured Label Content

Purpose

Skin Protectant

Cough Suppressant

Topical Analgesic

Warnings

Warnings

For external use only.

Do not use on ■ on deep wounds ■ serious burns ■ by mouth ■ in nostrils ■ with tight bandages ■ with heat ■ in a vaporizor

Avoid contact with eyes. Rinse with water to remove eyes. Rinse with water to remove.

Stop use and ask a doctor if you ■ nasal congestion gets worse ■ condition worsens ■ symptoms last more than 7 days or clears up and occurs again within a few days

Ask Doctore before use if you ■ have cough with excessive mucus ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ if pregnant or breast-feeding ■ children under 2 years

Indications & Usage

■ helps prevent and temporarily protects and helps relieve ■ chapped or cracked skin

■ when applied to the chest, throat, and bottom of feet, temporarily relieves cough due to minor throat and bronchial irritation associated with a cold

■ temporarily relieves minor aches and pains of muscles and joints

Inactive Ingredients

Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax), Organic Ricinus Communis (Castor) Seed Oil, Organic Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Agathophyllum Aromatica (Ravensara) Leaf Oil.

Storage and Handling

Store at room temperature.

Otc Active Ingredients (OTC Active Ingredients)

Organic Calendula Officinalis (Calendula) Flower Oil

Eucalyptus Globulus (Eucalyptus) Oil

Mentha Piperita (Peppermint) Oil

Dosage & Administration

Rub gently on chest, neck or bottom of the feet. Apply 2-3 times a day.

Principal Display Panel

Keep Out of Reach of Children

Keep Out of Reach of Children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)