Label: TERRASIL FLEX PAIN RELIEF AND MUSCLE RUB- menthol cream

  • NDC Code(s): 24909-191-44
  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient and purpose: Menthol 4% (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

    Purified water, emulsifying wax, shea butter, cotton seed oil, sorbic acid (preservative), chamomile oil, jojoba oil, sage oil, vitamin B oil, olive oil, vegetable stearic acid (naturally sourced), magnesium oxide, silver oxide, zinc oxide

  • PRINCIPAL DISPLAY PANEL 

    Natural
    terrasil® FLEX
    PAIN RELIEF & MUSCLE RUB CREAM

    For Arthritis, Sore Muscles, Joint & Back Pain


    Terrasil

  • INGREDIENTS AND APPEARANCE
    TERRASIL FLEX PAIN RELIEF AND MUSCLE RUB 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL STEARATE (UNII: 06RI5UQA7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COTTONSEED OIL (UNII: H3E878020N)  
    SORBIC ACID (UNII: X045WJ989B)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SAGE OIL (UNII: U27K0H1H2O)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    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:24909-191-4444 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(24909-191) , label(24909-191)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!