Purpose Section
Skin Protectant
Astringent
External Analgesic
Cold Sore Relief Salve
FDA Label NDC 70994-105
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 Cold Sore Relief (NDC 70994-105). 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 section, otc active ingredients, indications & uses, keep out of reach of children section, warnings section, storage and handling, dosage & administration section, 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 1X (HPUS)
Organic Plantago Major (Plantain) Leaf Extract 1X (HPUS)
Organic Stellaria Media (Chickweed) Extract 1X (HPUS)
Organic Symphytum Officinale (Comfrey) Leaf Powder 1X (HPUS)
Organic Achillea Millefofolium (Yarrow) Extract 1X (HPUS)
Commiphora Myrrha (Myrrh) Resin 1X (HPUS)
Organic Salvia Officinalis (Sage) Leaf 1X (HPUS)
Organic Hypericum Perforatum (St. Johns Wort) Oil 1X (HPUS)
Indications & Uses
• temporarily protects minor • cold sores • fever blisters
• temporarily protects and helps relieve • chapped or cracked lips
• helps protect from the drying effects of wind and cold weather
• temporarily protects and helps relieve minor skin irritation and itching due to • cold sores • fever blisters
• temporarily protects and helps relieves minor pain associated with • cold sores • fever blisters
Keep Out Of Reach Of Children Section
Keep out of reach of children.
Warnings Section
Warnings
For external use only.
-Do not use 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
-When using this product keep out of eyes. Rinse with water to remove.
Storage And Handling
Store at room temperature.
Dosage & Administration Section
Apply as often as needed to affected area.
Inactive Ingredients
Organic Olea Europaea (Olive) Fruit Oil, Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Cera Alba (Beeswax), Organic Melissa Officinale (Lemon Balm) Leaf Oil, Styrax Benzoin (Gum Benzoin) Gum, Organic Larrea Tridentata (Chapparal) Extract, Tocopherol (Vitamin E), Rosemarinus Officinalis (Rosemary) Leaf Oil, Lavandula Angustifolia (Lavender) Oil.
Principal Display Panel
Cold Sore Relief (Cold Sore)
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