Label: CASTIVA COOLING- menthol and methyl salicylate cream

  • 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 June 19, 2020

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  • SPL UNCLASSIFIED SECTION

    Castiva Cooling

    Drug Facts

  • Active Ingredient

    Menthol 5%

  • Purpose

    Topical Analgesic

  • Active Ingredient

    Methyl Salicylate 14%

  • Purpose

    Topical Analgesic

  • Use

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

  • Warnings

    For external use only. 

    Allergy alert. If prone to allergic reaction from aspirin or salicylate, consult a doctor before use.

    Do not use

    otherwise than as directed, on damaged skin, on open wounds, with a heating pad.

    Stop and ask a doctor if

    condition worsens, symptoms persist for more than 7 days, or clear up and occur again within a few days.

    When using this product

    avoid contact with eyes. Do not bandage tightly.

    If pregnant or breast feeding,

    ask a health professional before use.

    Keep out of reach of children 

    to prevent accidental poisoning. In case of accidental ingestion, seek professional assistance, or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 12 yrs. of age and older. Apply to the affected area no more than 3 to 4 times daily.
    • Children under 12 years of age: Consult a doctor.
  • Other Information

    • Store at room temperature.
  • Inactive Ingredients

    Castor oil, diazolidinyl urea, glyceryl monostearate, isopropyl palmitate, lecithin, methylparaben, PEG-100 stearate, poloxamer 407, polyglyceryl 1, 3- disteareate, potato starch modified, propylene glycol, propylparaben, purified water, SD Alcohol 40-B.

  • PRINCIPAL DISPLAY PANEL

    CoolingCtn.jpgCoolingTube.jpgcooling

  • INGREDIENTS AND APPEARANCE
    CASTIVA COOLING 
    menthol and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE140 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-0129-941 in 1 CARTON12/01/2006
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2006
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-0129) , label(0395-0129) , analysis(0395-0129)
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