Label: INFLAMMATION THERAPY- calendula officinalis flowering top soap

  • 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 June 25, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Calendula Officinalis Extract - 1XReduces inflammation
  • INDICATIONS & USAGE

    Uses: Reduces skin inflammation.

  • WARNINGS

    Warnings:For external use only. When using this product do not get into eyes.

    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.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Lather in hands or on a washcloth and wash entire body. Rinse thoroughly. Gentle enough for the face and for daily use.

  • SPL UNCLASSIFIED SECTION

    Other information: For use on mild skin inflammation, or as directed by a physician.

  • INACTIVE INGREDIENT

    Inactive ingredients: Sodium Palmate, Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Coconut Acid, Palmitic Acid, Sodium Chloride, Butyrospermum Parkii (Shea) Butter*, Titanium Dioxide (CI 77891), Aspalathus Linearis Leaf, Cannabis Sativa Seed Oil, Yellow 10 (CI 47005), Tetrasodium EDTA, Tetrasodium Etidronate, Iron Oxides (CI 77499), Melia Azadirachta Seed Oil, Red 4 (CI 14700), Green 3 (CI 42053).

    *Certified Organic Ingredient

  • QUESTIONS

    Questions or comments? 631-842-8800 or visit www.SheaMoisture.com

  • PRINCIPAL DISPLAY PANEL

    Boxes

  • INGREDIENTS AND APPEARANCE
    INFLAMMATION THERAPY 
    calendula officinalis flowering top soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58666-3121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT ACID (UNII: 40U37V505D)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    CANNABIS SATIVA SEED (UNII: QE567Z26NG)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58666-3121-6141 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2013
    Labeler - Sundial Group LLC (832783430)
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