Label: TERRASIL BACK PAIN CREAM- menthol cream

  • NDC Code(s): 24909-199-01
  • 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 August 10, 2021

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  • Active Ingredients

    Menthol 4%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints associated with simple back ache.

  • Warnings

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

    Keep out of reach of children.

    If swallowed consult a physician.

  • Directions

    Adults and 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. May stain fabrics.

  • Inactive Ingredients

    Chamomile oil, cotton seed oil, emulsifying wax, jojoba oil, magnesium oxide, olive oil, purified water, sage oil, shea butter, silver stearate, sorbic acid (preservative), vitamin B oil, zinc oxide.

  • SPL UNCLASSIFIED SECTION

    401-432-7750 or www.aidance.com

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TERRASIL BACK PAIN CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-199
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    WATER (UNII: 059QF0KO0R)  
    SAGE OIL (UNII: U27K0H1H2O)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    SORBIC ACID (UNII: X045WJ989B)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETYL STEARATE (UNII: 06RI5UQA7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-199-0144 g in 1 JAR; Type 0: Not a Combination Product07/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/28/2021
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions018950611manufacture(24909-199) , label(24909-199)
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