Label: COLD SORE RELIEF- stellaria media, salvia officinalis, calendula officials, st. johns wort, rosemary oil, plantago major, commiphora myrrha, comfrey leaf, salvia officinalis, sunflower oil salve
- NDC Code(s): 70994-105-01, 70994-105-09
- 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 Section
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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
- Warnings Section
- Storage and Handling
- Dosage & Administration Section
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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
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INGREDIENTS AND APPEARANCE
COLD SORE RELIEF
stellaria media, salvia officinalis, calendula officials, st. johns wort, rosemary oil, plantago major, commiphora myrrha, comfrey leaf, salvia officinalis, sunflower oil salveProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70994-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (ACHILLEA MILLEFOLIUM FLOWER - UNII:YQR8R0SQEA) ACHILLEA MILLEFOLIUM FLOWER 1 [hp_X] in 19.8 g ST. JOHN'S WORT (UNII: UFH8805FKA) (ST. JOHN'S WORT - UNII:UFH8805FKA) ST. JOHN'S WORT 1 [hp_X] in 19.8 g STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR) STELLARIA MEDIA 1 [hp_X] in 19.8 g SALVIA OFFICINALIS WHOLE (UNII: M9C36LC10E) (SALVIA OFFICINALIS WHOLE - UNII:M9C36LC10E) SALVIA OFFICINALIS WHOLE 1 [hp_X] in 19.8 g CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER 1 [hp_X] in 19.8 g PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 1 [hp_X] in 19.8 g COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7) (COMMIPHORA MYRRHA WHOLE - UNII:UU81N77RI7) COMMIPHORA MYRRHA WHOLE 1 [hp_X] in 19.8 g COMFREY LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X) COMFREY LEAF 1 [hp_X] in 19.8 g Inactive Ingredients Ingredient Name Strength MELISSA OFFICINALIS (UNII: YF70189L0N) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) STYRAX BENZOIN RESIN (UNII: FE663Z8IRO) LAVENDER OIL (UNII: ZBP1YXW0H8) OLIVE OIL (UNII: 6UYK2W1W1E) YELLOW WAX (UNII: 2ZA36H0S2V) LARREA TRIDENTATA LEAF (UNII: PK0TXD049P) ROSEMARY OIL (UNII: 8LGU7VM393) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70994-105-09 1 in 1 BOX 04/02/2019 1 NDC:70994-105-01 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 04/02/2019 Labeler - Spry Life LLC (100791947)
