NURSING CREAM (CALENDULA OFFICINALIS, CHAMOMILLA RECUTITA, ALTHAEA OFFICINALIS) SALVE [SIERRA SAGE HERBS LLC]

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NURSING CREAM (CALENDULA OFFICINALIS, CHAMOMILLA RECUTITA, ALTHAEA OFFICINALIS) SALVE [SIERRA SAGE HERBS LLC]
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NDC 70994-503-01, 70994-503-02, 70994-503-08, 70994-503-10
Set ID 4832b2c4-fc6b-26d6-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Sierra Sage Herbs LLC
Generic Name
Product Class
Product Number
Application Number
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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:70994-503-0119.8 g in 1 CAN; Type 0: Not a Combination Product04/01/2016
    3NDC: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 - Sierra Sage Herbs LLC (006970452)
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