KISS-ON LIP BALM (CALENDULA OFFICIALS FLOWERS) SALVE [SIERRA SAGE HERBS LLC]

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KISS-ON LIP BALM (CALENDULA OFFICIALS FLOWERS) SALVE [SIERRA SAGE HERBS LLC]
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NDC 70994-404-07, 70994-404-12
Set ID 48c1c11d-292e-5e48-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Sierra Sage Herbs LLC
Generic Name
Product Class
Product Number
Application Number
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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.

    • Don’t use on damaged or broken skin.
    • When using this product keep out of eyes. Rinse with water to remove.

    • Stop using and ask a doctor if rash or irritation occurs.

  • 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, Vanilla Absolute Extract, Cinnamon Bark Essential Oil, Coconut Flavor.

  • Principal Display Panel

    Kiss-on Lip Balm

  • INGREDIENTS AND APPEARANCE
    KISS-ON LIP BALM 
    calendula officials flowers salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70994-404
    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
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COCONUT (UNII: 3RT3536DHY)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    VANILLA (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70994-404-121 in 1 BOX04/01/2016
    1NDC:70994-404-074.25 g in 1 TUBE; Type 0: Not a Combination Product
    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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