WELLNESS PRODUCTS J-FLEX (CAPSAICIN) CREAM [WELLNESS PRODUCTS]

WELLNESS PRODUCTS J-FLEX (CAPSAICIN) CREAM [WELLNESS PRODUCTS]
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NDC 49671-001-04
Set ID d9a1b8d4-89c5-41ff-985a-b99a31218dff
Category HUMAN OTC DRUG LABEL
Packager Wellness Products
Generic Name
Product Class
Product Number
Application Number PART348
  • Wellness Products J-FLEX


  • Active Ingredient

    Capsaicin..................0.07%

  • Uses

    Use for temporary relief of minor aches and pains of muscles and joints associated with:

    • Simple backache
    • Arthritis
    • Bruises
    • Strains and/ or sprians
  • Warnings

    For external use only. Avoid contact with eyes.

    Do not apply

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

    If symptoms persist for more than seven days,

    discontinue use and consult physician.

    Keep out of reach of children

    If swallowed, consult physician.

  • Directions

    Apply directly to affected area.  Do not use more than four times a day.

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin-C), Carbomer, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil, Glucosamine Sulfate, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Polysorbate-20, Sorbitor, Triethanolamine.

  • Purpose

    Pain Relief

  • PRINCIPAL DISPLAY PANEL

    WELLNESS PRODUCTS  

    J-FLEX 
    Made in U.S.A.  

    Arthritis, Muscle and Joint Pain Relief Cream   

    NET WT   4 OZ / 118g  


    Distributed by:
    Wellness Products Corporation
    Brooklyn, NY 11224
    www.healthcrate.com

  • Wellness Products J-FLEX 4oz/118g

    JFLEX

  • INGREDIENTS AND APPEARANCE
    WELLNESS PRODUCTS J-FLEX 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49671-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.07 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EMU OIL (UNII: 344821WD61)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49671-001-041 in 1 CARTON02/10/2017
    1118 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 finalpart34804/12/2012
    Labeler - Wellness Products (078453111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(49671-001)

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