FASTRIN INFECTION CONTROL SKIN REPAIR (BENZETHONIUM CHLORIDE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]

FASTRIN INFECTION CONTROL SKIN REPAIR (BENZETHONIUM CHLORIDE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC 24909-602-10, 24909-602-50
Set ID e219428c-a1b7-4b44-85d4-58a69f629f74
Category HUMAN OTC DRUG LABEL
Packager Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active Ingredient

    Benzethonium Chloride 0.2%

  • Purpose

    Topical Antiseptic

  • Uses

    Helps reduce the risk of skin infection.

  • 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. Do not use on deep or puncture wounds, animal bites or serious burns.

    Keep out of reach of children.

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

  • Directions

    Clean and dry affected skin. For wound care, apply ointment liberally at least once daily, then cover with sterile bandaging. For barrier protection, massage into skin 2 to 4 times daily. Store at room temperature.

  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL - 50g Tube

    Fastrin

    Infection Control

    Skin Repair Ointment

    Net WT 50g (1.76 oz.)

    Tube Label

  • INGREDIENTS AND APPEARANCE
    FASTRIN INFECTION CONTROL SKIN REPAIR 
    benzethonium chloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COTTONSEED OIL (UNII: H3E878020N)  
    HONEY (UNII: Y9H1V576FH)  
    JOJOBA OIL (UNII: 724GKU717M)  
    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:24909-602-1010 g in 1 JAR; Type 0: Not a Combination Product06/01/2017
    2NDC:24909-602-5050 g in 1 TUBE; Type 0: Not a Combination Product06/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2017
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-602) , label(24909-602)

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