Label: CASTIVA WARMING- capsaicin cream

  • NDC Code(s): 0395-0130-94
  • Packager: Humco Holding Group, Inc.
  • 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 22, 2020

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  • SPL UNCLASSIFIED SECTION

    Castiva Warming

    Drug Facts

  • Active Ingredient

    Capsaicin 0.035%

  • 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. Do not use on damaged skin, on 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. Avoid inhaling dried residue from application site which may cause sneezing, nasal irritation or tearing.

    Keep out of reach of children. 

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 yrs. of age and older. Apply to the affected area no more than 3 to 4 times daily. To achieve optimum pain relief, apply daily as directed. Transient burning may occur upon application, but generally disappears in several days. WASH HANDS THROUGHLY AFTER USE TO AVOID SPREADING LOTION TO THE EYES. If applying lotions to hands, wait 30 minutes before washing hands. .
    • Children under 12 years of age: Consult a doctor before use.
  • Other Information

    • Store at room temperature. Apply carefully. May stain clothes.
  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    CastivaW.jpgWarmingTube.jpg

  • INGREDIENTS AND APPEARANCE
    CASTIVA WARMING 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.35 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-0130-941 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.825672884analysis(0395-0130) , manufacture(0395-0130) , label(0395-0130)