Label: FREE TO BREATHE- calendula, eucalyptus,peppermint salve
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NDC Code(s):
70994-109-01,
70994-109-02,
70994-109-04,
70994-109-08, view more70994-109-09, 70994-109-10
- Packager: Spry Life LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 29, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Purpose
- OTC Active Ingredients
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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
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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
- Storage and Handling
- Dosage & Administration
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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.
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INGREDIENTS AND APPEARANCE
FREE TO BREATHE
calendula, eucalyptus,peppermint salveProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70994-109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER 1 [hp_X] in 100 g EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 1.63 g in 100 g MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA 1.63 g in 100 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) LAVENDER OIL (UNII: ZBP1YXW0H8) CRYPTOCARYA AGATHOPHYLLA LEAF OIL (UNII: XM00Z00H98) OLIVE OIL (UNII: 6UYK2W1W1E) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) ROSEMARY OIL (UNII: 8LGU7VM393) YELLOW WAX (UNII: 2ZA36H0S2V) CASTOR OIL (UNII: D5340Y2I9G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70994-109-04 17 g in 1 TUBE; Type 0: Not a Combination Product 03/06/2020 2 NDC:70994-109-10 1 in 1 BOX 03/06/2020 2 NDC:70994-109-02 51.7 g in 1 CAN; Type 0: Not a Combination Product 3 NDC:70994-109-08 113.4 g in 1 JAR; Type 0: Not a Combination Product 03/06/2020 4 NDC:70994-109-01 1 in 1 BOX 03/06/2020 4 NDC:70994-109-09 19.8 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/06/2020 Labeler - Spry Life LLC (100791947)
