Label: DRY SKIN SALVE- calendula officials flowers, chamollia recutita flowers, viola tricolor leaf, sambucus nigra flowers, trifolium pratense flowers, archillea millefolium salve

  • 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 10, 2023

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  • Purpose Section

    Skin Protectant

    Astringent

  • Active Ingredients

    OrganicAchilleaMillefolium(Yarrow)FlowerExtract1X(HPUS)

    Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)

    OrganicChamomillaRecutita(Matricaria)Flower 1X(HPUS)

    Organic Sambucus Nigra (Elder) Flower 1X (HPUS)

    Organic Trifolium Pratense (Red Clover) Flower 1X (HPUS)

  • Indications & Usage

    ■ temporarily protects minor ■ rashes ■ cracked skin ■ red bumps

    ■ helps prevent and temporarily protects and helps relieve ■ chapped or cracked skin

    ■ helps prevent and protect from the drying effects of wind and cold weather

    ■ temporarily protects and helps relieve minor skin irritation and itching due to

    ■ rashes ■ eczema ■ psoriasis ■ rough elbows ■ cracked hands ■ cracked feet

    ■ 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 ■ 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), Organic Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil.

  • Principal Display Panel

    Dry Skin

  • INGREDIENTS AND APPEARANCE
    DRY SKIN SALVE 
    calendula officials flowers, chamollia recutita flowers, viola tricolor leaf, sambucus nigra flowers, trifolium pratense flowers, archillea millefolium salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70994-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 51.7 g
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE1 [hp_X]  in 51.7 g
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER1 [hp_X]  in 51.7 g
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER1 [hp_X]  in 51.7 g
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM1 [hp_X]  in 51.7 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70994-111-0417 g in 1 TUBE; Type 0: Not a Combination Product04/01/2019
    2NDC:70994-111-091 in 1 BOX04/01/2019
    2NDC:70994-111-0119.8 g in 1 CAN; Type 0: Not a Combination Product
    3NDC:70994-111-101 in 1 BOX04/01/2019
    3NDC:70994-111-0251.7 g in 1 CAN; Type 0: Not a Combination Product
    4NDC:70994-111-08113.4 g in 1 JAR; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2019
    Labeler - Sierra Sage Herbs LLC (006970452)
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