FASTRIN ACHES AND PAIN DEEP RELIEF (MENTHOL, CAMPHOR) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]

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FASTRIN ACHES AND PAIN DEEP RELIEF (MENTHOL, CAMPHOR) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC 24909-604-10, 24909-604-50
Set ID 132af5e7-e6fc-4d25-98bd-79d2d8b61b6d
Category HUMAN OTC DRUG LABEL
Packager Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients

    Menthol 16%, Camphor 11%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

  • Warnings

    For external use only. Do not use on wounds or damaged skin. When using this product - avoid contact with eyes or mucous membranes - do not bandage tightly or use with heating pad. Stop use and ask a doctor if - condition worsens or symptoms persist for more than 7 days - symptoms clear up and occur again within a few days - excessive skin irritation develops.

    Keep out of reach of children.

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

  • Directions

    Adults and children 12 years and older: Massage ointment into affected area not more than 3 to 4 times daily. Children under 12 years of age: Ask a doctor.

  • Inactive Ingredients

    Beeswax, Clove Oil, Cottonseed Oil, Eucalyptus Citriodora Oil, Jojoba Seed Oil, Magnesium Oxide, Peppermint Oil, Silver Oxide, Sorbic Acid, Tea Tree Oil, Zinc Oxide

  • PRINCIPAL DISPLAY PANEL - 50g Tube

    Fastrin

    Aches & Pain

    Deep Relief Ointment

    Net WT 50g (1.76 oz.)

    Tube Label

  • INGREDIENTS AND APPEARANCE
    FASTRIN ACHES AND PAIN DEEP RELIEF 
    menthol, camphor ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CLOVE OIL (UNII: 578389D6D0)  
    CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)  
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    SORBIC ACID (UNII: X045WJ989B)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-604-1010 g in 1 JAR; Type 0: Not a Combination Product06/01/2017
    2NDC:24909-604-5050 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 finalpart34806/01/2017
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-604) , label(24909-604)
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