Label: CAPSADYN- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 11, 2023

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  • PURPOSE

    Topical analgesic

  • ACTIVE INGREDIENT

    Capsaicin 0.25% as Capsaicin palmitate

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, muscle strains, sprains, bruises, related muscle injuries, and simple backache. Provides penetrating pain relief.

  • WARNINGS

    For external use only.

    Do not apply to wounds and damaged skin.

    When using this product use only as directed, temporary warming of skin may be experienced after application, avoid contact with eyes or mucous membranes, do not bandage tightly, do not expose the treated area to heat, and avoid activity that may cause perspiration.

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Adults and children 18 years of age and older:

    apply to affected areas not more than 3-4 times daily, rub in the cream until completely absorbed, the amount used depends on the depth of the pain, typically provides pain relief without any noticeable warming or cooling, wash hands thoroughly with soap and water after applying.

    Children under 18 years of age: consult a doctor.

  • INACTIVE INGREDIENT

    Butyrospermum parkii (shea) butter, ceteareth-20, cetyl alcohol, cocos nucifera (coconut) oil, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, myristyl myristate, phenoxyethanol, polysorbate 20, stearic acid, water.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    CAPSADYN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83009-169
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83009-169-0128 g in 1 JAR; Type 0: Not a Combination Product10/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/13/2023
    Labeler - Chorda Pharma, Inc (099853035)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(83009-169)