Label: SALVACINE- calendula officials, plantago major, olea europaea, achillea millefolium salve

  • NDC Code(s): 70994-801-02, 70994-801-10
  • 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 January 9, 2024

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  • Purpose Section

    Skin Protectant

    Astringent

  • Active Ingredients

    Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)
    Organic Plantago Major (Plantain) Leaf Extract 1X (HPUS)

    Organic Olea Europaea (Olive) Leaf Oil 1X (HPUS)

    OrganicAchilleaMillefolium(Yarrow)Extract1X(HPUS)

  • Indications & Usage

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

    ▪︎ temporarily protects and helps relieve • chapped or cracked skin

    ▪︎ helps protect from the drying effects of wind and cold weather
    ▪︎ temporarily protects and helps relieve minor skin irritations and itching due to • cracked hands and cracked feet • minor rashes • rashes caused by soaps, detergents, cosmetics, or jewelry

  • 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

    Store at room temperature.

  • Dosage & Administration Section

    • clean affected area • Apply as often as needed • can be covered with strile bandage

  • Inactive Ingredients

    Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax), Organic Ricinus Communis (Castor) Seed Oil, Lavandula Angustifolia (Lavender) Oil, Tocopherol (Vitamin E), Rosmarinus Officinalis (Rosemary) Leaf Oil.

  • Principal Display Panel

    Salvacine

  • INGREDIENTS AND APPEARANCE
    SALVACINE 
    calendula officials, plantago major, olea europaea, achillea millefolium salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70994-801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) (OLEA EUROPAEA LEAF - UNII:MJ95C3OH47) OLEA EUROPAEA LEAF1 [hp_X]  in 100 g
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (ACHILLEA MILLEFOLIUM FLOWER - UNII:YQR8R0SQEA) ACHILLEA MILLEFOLIUM FLOWER1 [hp_X]  in 100 g
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 g
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR1 [hp_X]  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70994-801-101 in 1 BOX08/29/2022
    1NDC:70994-801-0251.7 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/29/2022
    Labeler - Spry Life LLC (100791947)
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