Label: TERRASIL FLEX -PAIN RELIEF AND MUSCLE RUB MAX- menthol ointment

  • NDC Code(s): 24909-192-44
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • 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 July 22, 2019

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  • ACTIVE INGREDIENT

    Active ingredient and purpose: Menthol 8% (Topical Analgesic)

  • PURPOSE

  • Uses

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

  • Warnings

    For external use only. Do not use on wounds or damaged skin and avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

    Keep out of reach of children. If swallowed, consult a physician.

  • Directions

    Adults & children 12 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age – consult a physician.

  • Inactive Ingredients

    Cotton seed oil, beeswax, sorbic acid (preservative), arnica oil, chamomile oil, jojoba seed oil, sage oil, olive oil, vegetable stearic acid (naturally sourced), magnesium oxide, silver oxide, zinc oxide

  • PRINCIPAL DISPLAY PANEL 

    Natural
    terrasil® FLEX MAX
    PAIN RELIEF & MUSCLE RUB OINTMENT

    For Arthritis, Sore Muscles, Joint & Back Pain

    Terrasil

  • INGREDIENTS AND APPEARANCE
    TERRASIL FLEX -PAIN RELIEF AND MUSCLE RUB MAX 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-192
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COTTONSEED OIL (UNII: H3E878020N)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SORBIC ACID (UNII: X045WJ989B)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SAGE OIL (UNII: U27K0H1H2O)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-192-4444 g in 1 JAR; Type 0: Not a Combination Product08/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/06/2019
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-192) , label(24909-192)
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