Label: FOOT CARE- calendula officials, stellaria media, st. johns wort, rosemary oil, plantago major, commiphora myrrha, comfrey leaf, salvia officinalis, sunflower oil salve

  • NDC Code(s): 70994-202-02, 70994-202-04, 70994-202-08, 70994-202-10
  • 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 March 11, 2020

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

  • Purpose Section

    Skin Protectant

    Astringent

    External Analgesic

  • 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)

    OrganicAchilleaMillefolium(Yarrow)Extract1X(HPUS)

    Commiphora Myrrha (Myrrh) Resin 1X (HPUS)

    Organic Salvia Officinalis (Sage) Leaf 1X (HPUS)
    Organic Hypericum Perforatum (St. John’s Wort) Oil 1X (HPUS).

  • Indications & Usage

    -temporarily protects minor • cuts • scrapes • abrasions • blisters • burns

    -helps prevent and temporarily protects and helps relieve • cracked skin and heels

    -helps protect from the drying effects of wind and cold weather

    -Temporarily protects and helps relieve minor skin irritation and itching due to • itchy rashes • poison ivy • insect bites • rashes caused by soaps, detergents, cosmetics, or jewelry

    -temporarily protects and helps relieve minor pain associated with • blisters • scrapes • abrasions • bruises • cuts • minot burns • ingrown toenails

  • Keep out of reach of children section

    Keep out of reach of children.

  • Warnings Section

    Warnings

    For external use only.

    - Do not use on • 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

    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), Styrax Benzoin Gum, Organic Larrea Tridentata (Chapparal) Extract, Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil.

  • Principal Display Panel

    Foot Care PDP

  • INGREDIENTS AND APPEARANCE
    FOOT CARE 
    calendula officials, stellaria media, 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:70994-202
    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 51.7 g
    ST. JOHN'S WORT (UNII: UFH8805FKA) (ST. JOHN'S WORT - UNII:UFH8805FKA) ST. JOHN'S WORT1 [hp_X]  in 51.7 g
    STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR) STELLARIA MEDIA1 [hp_X]  in 51.7 g
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 51.7 g
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR1 [hp_X]  in 51.7 g
    COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7) (COMMIPHORA MYRRHA WHOLE - UNII:UU81N77RI7) COMMIPHORA MYRRHA WHOLE1 [hp_X]  in 51.7 g
    SALVIA OFFICINALIS WHOLE (UNII: M9C36LC10E) (SALVIA OFFICINALIS WHOLE - UNII:M9C36LC10E) SALVIA OFFICINALIS WHOLE1 [hp_X]  in 51.7 g
    COMFREY LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X) COMFREY LEAF1 [hp_X]  in 51.7 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70994-202-0417 g in 1 TUBE; Type 0: Not a Combination Product02/06/2019
    2NDC:70994-202-101 in 1 BOX04/01/2016
    2NDC:70994-202-0251.7 g in 1 CAN; Type 0: Not a Combination Product
    3NDC:70994-202-08113.4 g in 1 JAR; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2016
    Labeler - Sierra Sage Herbs LLC (006970452)