FASTRIN INCONTINENCE AND OSTOMY RASH CARE (CALENDULA, COMFREY, THUJA OCCIDENTALIS) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]

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FASTRIN INCONTINENCE AND OSTOMY RASH CARE (CALENDULA, COMFREY, THUJA OCCIDENTALIS) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC 24909-603-10, 24909-603-50
Set ID 3af07373-2bbc-4428-bb63-4313dc1dd8b5
Category HUMAN OTC DRUG LABEL
Packager Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class
Product Number
Application Number
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  • Active Ingredient

    Calendula officinalis 1X HPUS, Comfrey (Symphytum officinale) 1X HPUS, Thuja occidentalis 3X HPUS

  • Purpose

    Calendula - Healing Agent, Comfrey - Anti-Inflammatory, Thuja - Irritation Relief

  • Uses

    Helps relieve and prevent rashes and irritation due to wetness from incontinence. Helps prevent infection.

  • Warnings

    For external use only. Do not get into eyes.

    Keep out of reach of children.

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

  • Directions

    Clean and dry affected skin. Apply a thin layer of ointment over the affected area. Repeat 1 to 3 times daily or as needed.

  • Inactive Ingredients

    Beeswax, Cottonseed Oil, Jojoba Seed Oil, Magnesium Oxide, Manuka Honey, Peppermint Oil, Silver Oxide, Tea Tree Oil, Zinc Oxide

  • PRINCIPAL DISPLAY PANEL - 50g Tube

    Fastrin

    Incontinence & Ostomy

    Rash Care Ointment

    Net WT 50g (1.76 oz.)

    Tube Label

  • INGREDIENTS AND APPEARANCE
    FASTRIN INCONTINENCE AND OSTOMY RASH CARE 
    calendula, comfrey, thuja occidentalis ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-603
    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 100 g
    COMFREY (UNII: D05HXK6R3G) (COMFREY - UNII:D05HXK6R3G) COMFREY1 [hp_X]  in 100 g
    THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N) THUJA OCCIDENTALIS WHOLE3 [hp_X]  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COTTONSEED OIL (UNII: H3E878020N)  
    HONEY (UNII: Y9H1V576FH)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-603-1010 g in 1 JAR; Type 0: Not a Combination Product06/01/2017
    2NDC:24909-603-5050 g in 1 TUBE; Type 0: Not a Combination Product06/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2017
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-603) , label(24909-603)
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