Label: FASTRIN INCONTINENCE AND OSTOMY RASH CARE- calendula, comfrey, thuja occidentalis 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 June 1, 2017

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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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