Label: CITRUS ZEST LIP BALM- calendula officials flowers 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 December 29, 2023

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  • Purpose Section

    Skin Protectant

  • Active Ingredients

    Organic Calendula Officinalis (Calendula) Flowers 1X (HPUS)

  • Indications & Usage

    • temporarily helps relieve • chapped or cracked lips
    • helps protect from the drying effects of wind and cold weather
    • temporarily protects and helps relieve minor skin irritations due to • chaffing • redness • windburn • sun exposure
    • temporarily helps moisturize • chapped and cracked lips

  • Keep out of reach of children section

    Keep out of reach of children.

  • Warnings Section

    Warnings

    For external use only.

    ■ Do not use on ■ deep wounds ■ animal bites ■ serious burns

    ■ Stop use and ask a doctor if conditions 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 Beeswax (Cera alba), Organic Cocos nucifera (Coconut) Oil, Organic Jojoba (Simmondsia Chinensis) Oil, Organic Helianthus annuus (Sunflower) Oil, Organic Olive (Olea europaea) Oil, Non-GMO (100% Sunflower) Mixed Tocopherols (Vitamin E) Oil. Essential Oils of Sweet Orange and Lemon.

  • Principal Display Panel

    Green Goo Citrus Lip Balm

  • INGREDIENTS AND APPEARANCE
    CITRUS ZEST LIP BALM 
    calendula officials flowers salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70994-402
    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
    Inactive Ingredients
    Ingredient NameStrength
    ORANGE OIL (UNII: AKN3KSD11B)  
    LEMON OIL (UNII: I9GRO824LL)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70994-402-074.25 g in 1 TUBE; 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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