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THERAID (SOMBRA COSMETICS INC.)

Available Formats

Dosage Form Package Information Links
GEL 36.9 g in 1 JAR (61577-3710-2) Label Information
GEL 113.4 g in 1 JAR (61577-3710-1) Label Information

Complete THERAID Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:61577-3710
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .04 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61577-3710-1 113.4 g in 1 JAR
    2 NDC:61577-3710-2 36.9 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 02/20/2013
    Labeler - SOMBRA COSMETICS INC. (097464309)
    Registrant - SOMBRA COSMETICS INC. (097464309)
    Establishment
    Name Address ID/FEI Business Operations
    SOMBRA COSMETICS INC. 097464309 manufacture(61577-3710) , label(61577-3710)