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: Sierra Sage Herbs 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 January 9, 2021

If you are a consumer or patient please visit this version.

  • Purpose Section

    Skin Protectant

    Astringent

    External Analgesic

  • 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

  • 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 salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70994-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (ACHILLEA MILLEFOLIUM FLOWER - UNII:YQR8R0SQEA) ACHILLEA MILLEFOLIUM FLOWER1 [hp_X]  in 19.8 g
    ST. JOHN'S WORT (UNII: UFH8805FKA) (ST. JOHN'S WORT - UNII:UFH8805FKA) ST. JOHN'S WORT1 [hp_X]  in 19.8 g
    STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR) STELLARIA MEDIA1 [hp_X]  in 19.8 g
    SALVIA OFFICINALIS WHOLE (UNII: M9C36LC10E) (SALVIA OFFICINALIS WHOLE - UNII:M9C36LC10E) SALVIA OFFICINALIS WHOLE1 [hp_X]  in 19.8 g
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 19.8 g
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR1 [hp_X]  in 19.8 g
    COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7) (COMMIPHORA MYRRHA WHOLE - UNII:UU81N77RI7) COMMIPHORA MYRRHA WHOLE1 [hp_X]  in 19.8 g
    COMFREY LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X) COMFREY LEAF1 [hp_X]  in 19.8 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70994-105-091 in 1 BOX04/02/2019
    1NDC:70994-105-0119.8 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2019
    Labeler - Sierra Sage Herbs LLC (006970452)