Label: DUSEL WARM ARTHRITIS DEAD SEA SALT THERAPY- capsaicin 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 February 16, 2017

If you are a consumer or patient please visit this version.

  • Drug Facts:
  • Active Ingredient:

    Capsaicin 0.025%

    Topical Analgesic

    Close
  • Indications:

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

    Close
  • Warnings:

    • For external use only.
    • Avoid contact with eyes.
    • If symptoms persist for more than seven days, discontinue use and consult physician

    Keep out of reach of children.

    If swallowed, consult physician.

    Do not apply

    • to wounds or damaged skin.
    • Do not bandage tightly.

    If pregnant or breast feeding,

    • contact physician prior to use.

    Close
  • Directions:

    •Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
    •Children under two-years of age: consult a physician.

    Close
  • Additional Information:

    Store at room temperature.

    Close
  • Other Ingredients:

    Aqua (Deionized Water), Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose Isopropyl Myristate, Maris Sal (Dead Sea) Salt, Phenoxyethanol, Polysorbate-20, Sea (Dead) Salt, (Corn) Zemea Propanediol.

    Close
  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    DUSEL WARM ARTHRITIS DEAD SEA SALT THERAPY 
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70656-742
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.25 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SEA SALT (UNII: 87GE52P74G)  
    CORN (UNII: 0N8672707O)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70656-742-01 113 g in 1 JAR; Type 0: Not a Combination Product 04/26/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 04/26/2016
    Labeler - Nanovita One LLC (080217774)
    Close