Label: FASTRIN ACHES AND PAIN DEEP RELIEF- menthol, camphor cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 1, 2017

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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, Distilled Water, Emulsifying Wax, Eucalyptus Oil, Jojoba Seed Oil, Magnesium Oxide, Peppermint Oil, Shea Butter, Silver Oxide, Sorbic Acid, Tea Tree Oil, Zinc Oxide

  • PRINCIPAL DISPLAY PANEL - 50g Tube

    Fastrin

    Aches & Pain

    Deep Relief Cream

    Net WT 50g (1.76 oz.)

    Tube Label

  • INGREDIENTS AND APPEARANCE
    FASTRIN ACHES AND PAIN DEEP RELIEF 
    menthol, camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-605
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    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)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    SORBIC ACID (UNII: X045WJ989B)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-605-1010 g in 1 JAR; Type 0: Not a Combination Product06/01/2017
    2NDC:24909-605-5050 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(24909-605) , label(24909-605)
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