Label: THERAID- menthol gel

  • 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 February 20, 2013

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

View All Sections
  • Active Ingredients

    Menthol USP 4%

  • Purpose

    Purpose

    External Analgesic
  • Keep out of reach of children

    Keep out of reach of children

  • Uses

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

  • Warnings

    For external use only.  Do not use on wounds or damaged skin.  When using this product:  avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

    Stop use and ask doctor if:  condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

  • Directions

    adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

  • Inactive Ingredients

    aloe vera extract, capsaicin, carbomer, decyl polyglucose, deionized water, emu oil, grapefruit seed extract, orange peel extract, sodium  hydroxymethylglycinate, vegetable glycerin, witch hazel, yucca extract

  • Questions or Comments

    1-888-416-4441

  • PRINCIPAL DISPLAY PANEL


    label



    theraid.jpg

  • INGREDIENTS AND APPEARANCE
    THERAID  
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-3710
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPSICUM (UNII: 00UK7646FG)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    WATER (UNII: 059QF0KO0R)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    EMU OIL (UNII: 344821WD61)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-3710-1113.4 g in 1 JAR
    2NDC:61577-3710-236.9 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/20/2013
    Labeler - SOMBRA COSMETICS INC. (097464309)
    Registrant - SOMBRA COSMETICS INC. (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS INC.097464309manufacture(61577-3710) , label(61577-3710)
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!