Label: PENETREX(R) ARTHRITIS PAIN RELIEF- capsaicin cream

  • NDC Code(s): 62742-4216-1, 62742-4216-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 20, 2022

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

  • ACTIVE INGREDIENT

    Active ingredient

    Capsaicin 0.025%

  • PURPOSE

    Purpose

    Topical analgesic

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves minor pains of muscles and joints associated with arthritis,simple backache,muscle strains,bruises,sprains,cramps

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    on wounds, damaged, or irritated skin

    with a heating pad

    if you are alergic to capsicum or chili peppers

  • WHEN USING

    When using this product

    Read directions befbre using

    use only as directed; read and follow all directions and warnings on this carton rare cases of serious bums have been reported with products of this type

    do not bandage tightly or apply local heat (such as heating pads) to the area of use

    avoid contact with eyes and mucous membranes

    do not apply to wounds or damaged, broken or irritated skin

    a transient burning sensation may occur upon application but generally disappears in several days

    if severe burning occurs, discontinue use immediately

    do not expose the area treated With product to heat or direct sunlight

    do not use at the same time as other topical analgesics,

  • STOP USE

    Stop use and ask a doctor if

    condition worsens

    redness is present

    irritation develops

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

    you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 18 years of age and older:

    apply to affected area but no more than 3 to 4 times daily

    massage onto painful area until thoroughly absorbed

    IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    Children under 18 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    If pregnant or breast-feeding, ask a health professional before use

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water (Aqua),Helanthus Annuus (Sunflower) Seed Oil, Glycerin,GlycerylStearates, Amica Montana Flower Extract,

    Cetearyl Alcohol,Ceteareth-20,PEG-100 Stearate, Butyrospermum Parkii (Shea) Buffer,Cetyl Esters,Ammonium Acryloyldimethyltaurate/VP Copolymer, Aloe Barbadensis Leaf Juice,Dimethicone, Ethoxydiglycol, Phenoxyethanol,

    Methyl Gluceth-20,Menthe Piperita Oil,Camphor,Ethylhexylglycerin,Potassium Sorbate, Glucosamine HCI,Choline Bitartrate,

    Pyridoxine HCL, Glycyrrhizinate Dipotassium, Methyl sulfonyl Methane,Disodium EDTA, Boswellia carterii oil,

    Sodium Benzoate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol, Citric Acid,Beta-Sitosterol, Squalene.

  • PRINCIPAL DISPLAY PANEL

    Arthritispainrelief

  • INGREDIENTS AND APPEARANCE
    PENETREX(R) ARTHRITIS PAIN RELIEF 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    SQUALENE (UNII: 7QWM220FJH)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4216-21 in 1 CARTON06/20/2022
    1NDC:62742-4216-157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/20/2022
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4216)