Label: NURSING CREAM- calendula officinalis, chamomilla recutita, althaea officinalis salve

  • NDC Code(s): 70994-503-02, 70994-503-08, 70994-503-10
  • 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

  • OTC Active Ingredients

    Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)
    Organic Chamomilla Recutita (Matricaria) Flower Oil 1X (HPUS)
    Organic Althaea Officinalis (Marshmallow) Root 1X (HPUS)

  • Indications & Usage

    ■ temporarily protects skin related to ■ nursing ■ pregnancy

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

    ■ temporarily protects and helps relieve minor skin irritation

  • 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

    Clean and dry nipple area before application. Apply as often as needed. Clean and dry nipple area before nursing.

  • Inactive Ingredients

    Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax).

  • Principal Display Panel

    Nursing PDP

  • INGREDIENTS AND APPEARANCE
    NURSING CREAM 
    calendula officinalis, chamomilla recutita, althaea officinalis salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70994-503
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) (ALTHAEA OFFICINALIS ROOT - UNII:TRW2FUF47H) ALTHAEA OFFICINALIS ROOT1 [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
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE1 [hp_X]  in 51.7 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70994-503-101 in 1 BOX04/01/2016
    1NDC:70994-503-0251.7 g in 1 CAN; Type 0: Not a Combination Product
    2NDC:70994-503-08113.4 g in 1 JAR; Type 0: Not a Combination Product02/06/2019
    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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