Purpose
Skin Protectant
Cough Suppressant
Topical Analgesic
Free To Breathe Salve
FDA Label NDC 70994-109
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spry Life Llc for the product Free To Breathe (NDC 70994-109). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding purpose, otc active ingredients, indications & usage, warnings, keep out of reach of children, storage and handling, dosage & administration, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc Active Ingredients
Organic Calendula Officinalis (Calendula) Flower Oil
Eucalyptus Globulus (Eucalyptus) Oil
Mentha Piperita (Peppermint) Oil
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
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
Keep Out Of Reach Of Children
Keep Out of Reach of Children.
Storage And Handling
Store at room temperature.
Dosage & Administration
Rub gently on chest, neck or bottom of the feet. Apply 2-3 times a day.
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.
Principal Display Panel
Free To Breathe Hanger (Free To Breathe Large Hanger V9)
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