Label: TONYS WARM THERAPY- menthol camphor 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 September 13, 2021

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  • Active Ingredients

    Menthol USP 3%, Camphor USP 3%

  • Purpose

    Purpose

    External Analgesic

  • Keep out of reach of Children

    ​Keep out of reach of children

  • Uses

    Temporarily relieves minor arches and pains of muscles and joints associated with: arthritis, simple backaches.

  • warnings

    ​For external use only. ​Do not use on wounds or damage skin. When using this product :​ avoid bandaging tightly, aviod contact with eyes, ​keep out of mreach of childern​.

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

  • Directions

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

  • Inactive Ingredients

    aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus aurantium dulcis (orange) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol, capsicum annuum fruit extract

  • Questions or Comments

    1-800-225-3963

  • PRINCIPAL DISPLAY PANEL

    Dr Tony Warm Therapy

  • INGREDIENTS AND APPEARANCE
    TONYS WARM THERAPY 
    menthol camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-1400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.03 g  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    WATER (UNII: 059QF0KO0R)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-1400-385 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/13/2021
    Labeler - Sombra Cosmetics (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sombra Cosmetics097464309manufacture(61577-1400)
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