Label: MOM OF 11 KIDS NO TIME FOR CUTS, SCRAPES AND BURNS- calendula ointment

  • 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 August 20, 2015

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  • Active Ingredients

    Calendula 1X HPUS

  • Purpose

    Calendula - Healing agent

  • Uses

    Promotes healing from minor cuts, scrapes, burns and skin irritations.

  • Warnings

    For external use only. Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days. When using this product avoid contact with eyes.

    Keep out of reach of children.

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

  • Directions

    Apply a thin layer to clean, dry skin up to 3 times daily. Cover with sterile bandage. Continue until skin improves.

  • Inactive Ingredients

    Beeswax (organic), Chamomile Oil, Cotton Seed Oil, Jojoba Seed Oil (golden), Kokum Butter, Magnesium Oxide, Silver Oxide, Zinc Oxide.

  • PRINCIPAL DISPLAY PANEL - 30g Label

    Mom of 11 Kids™

    NO TIME FOR™
    Cuts, Scrapes & Burns
    Advanced First Aid Ointment
    Safe & Natural is Finally Fast & Effective™
    Net Wt. 1.1 oz. (30g)

    Jar Label

  • INGREDIENTS AND APPEARANCE
    MOM OF 11 KIDS NO TIME FOR CUTS, SCRAPES AND BURNS 
    calendula ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-509
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER6 [hp_X]  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GARCINIA INDICA FRUIT (UNII: 0Q3R71D98M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-509-3030 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:24909-509-1818 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/10/2015
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-509) , label(24909-509)
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