Label: BABY BALM- calendula officinalis, chamomilla recutita, archillea millefolium, symphytum officinalis, helianthus annuus salve

  • NDC Code(s): 70994-501-02, 70994-501-04, 70994-501-08, 70994-501-10
  • 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 December 29, 2023

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  • OTC Purpose

    Skin Protectant

    Astringent

  • OTC Active Ingredients

    Organic Achillea Millefolium (Yarrow) Flower Extract 1X (HPUS)

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

    Organic Chamomilla Recutita (Matricaria) Flower 1X (HPUS
    Organic Symphytum Officinale (Comfrey) Leaf Powder 1X (HPUS)

  • Indications & Usage

    -temporarily protects minor • diapar rash • baby acne

    -helps prevent and 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 irritation and itching due to • cradle cap • diaper rash • baby acne • eczema • psoriasis • rashes

  • Warnings

    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.

  • Keep Out of Reach of Children

    Keep Out of Reach of Children

  • Storage and Handlin

    Store at room temperature.

  • Dosage & Administration

    Apply as often as needed to the affected area.

  • Inactive Ingredients

    Organic Olea Europaea(Olive) Fruit Oil,Organic Cera Alba (Beeswax), Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil.

  • Principal Display Panel

    Baby Balm

  • INGREDIENTS AND APPEARANCE
    BABY BALM 
    calendula officinalis, chamomilla recutita, archillea millefolium, symphytum officinalis, helianthus annuus salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70994-501
    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
    SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y) SYMPHYTUM OFFICINALE WHOLE1 [hp_X]  in 51.7 g
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE1 [hp_X]  in 51.7 g
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (ACHILLEA MILLEFOLIUM FLOWER - UNII:YQR8R0SQEA) ACHILLEA MILLEFOLIUM FLOWER1 [hp_X]  in 51.7 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    JOJOBA OIL (UNII: 724GKU717M)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70994-501-101 in 1 BOX04/01/2016
    1NDC:70994-501-0251.7 g in 1 CAN; Type 0: Not a Combination Product
    2NDC:70994-501-0417 g in 1 TUBE; Type 0: Not a Combination Product02/06/2019
    3NDC:70994-501-08113.4 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 - Spry Life LLC (100791947)
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