Label: BELLY BALM- rosehip seed oil salve

  • NDC Code(s): 70994-506-02, 70994-506-08, 70994-506-10
  • 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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  • Purpose Section

    Skin Protectant

  • Active Ingredients

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

    Organic Rosa Canina (Rosehip) Seed Extract 3.3%

  • Indications & Usage

    ■ temporarily protects minor ■ itchy skin ■ pregnant belly skin ■ stretch marks

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

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

  • 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 pregnant belly.

  • Inactive Ingredients

    Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax), Organic Simmondsia Chinensis (Jojoba) Seed Oil, Organic Butyrospermum Parkii (Shea) Butter, Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil.

  • Principal Display Panel

    Belly Balm

  • INGREDIENTS AND APPEARANCE
    BELLY BALM 
    rosehip seed oil salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70994-506
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROSA MOSCHATA OIL (UNII: J99W255AWF) (ROSA MOSCHATA OIL - UNII:J99W255AWF) ROSA MOSCHATA OIL3.3 g  in 100 g
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70994-506-101 in 1 BOX07/09/2019
    1NDC:70994-506-0251.7 g in 1 CAN; Type 0: Not a Combination Product
    2NDC:70994-506-08113.4 g in 1 JAR; Type 0: Not a Combination Product07/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/09/2019
    Labeler - Spry Life LLC (100791947)
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