Label: HOT STUFF- capsicum oleoresin cream

  • Category: HUMAN OTC DRUG LABEL

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 November 11, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Capsicum Oleoresin 0.0625%
    (Containing Capsaicin 0.025%)

  • Purpose

    Pain Relief

  • Uses

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

    • simple backache
    • arthritis
    • strains
    • sprains
  • Warnings

    For external use only.

    • do not apply to wounds or damaged skin
    • do not bandage tightly
    • do not use with heating pad, pack, wrap, hot water bottle or any heating element

    When using this product do not get into eyes

    • avoid contact with other mucous membranes

    Discontinue 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

    • if pregnant or nursing, seek the advice of a health professional before using
  • Directions

    • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
    • Children under 12 years of age consult a physician
    • Apply a thin layer to affected area not more than 3 to 4 times daily
    • Gently massage into the skin until fully absorbed
    • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
    • A burning sensation may occur upon initial application but generally disappears with continued use
    • For a severe burning discomfort, remove excess product wiht a soft cloth and mineral oil
  • Inactive ingredients

    Water (Aqua), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita (Peppermint) Oil, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide

  • Questions or comments?

    Call 1-800-356-9522 or Email us at sportcare@muellersportsmed.com

  • PRINCIPAL DISPLAY PANEL - 106 g Bottle Label

    MUELLER®

    Hot Stuff®
    Cream
    topical analgesic

    Warming Capsaicin formula
    delivers comforting,
    targeting relief

    HELPS TO RELIEVE PAIN
    ASSOCIATED WITH

    • Strains
    • Sprains
    • Muscle Aches & Pain
    • Arthritis
    • Joint Pain

    6h
    Timed-Release
    IcePearls™

    30805 LBL30805A - 9.16

    NET WT 3.75 OZ (106 g)

    PRINCIPAL DISPLAY PANEL - 106 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    HOT STUFF 
    capsicum oleoresin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52564-308
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN0.0265 g  in 106 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALFALFA (UNII: DJO934BRBD)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ROSEMARY (UNII: IJ67X351P9)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    GINKGO (UNII: 19FUJ2C58T)  
    FLAX SEED (UNII: 4110YT348C)  
    ACAI (UNII: 46AM2VJ0AW)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    EMU OIL (UNII: 344821WD61)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52564-308-02106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2016
    2NDC:52564-308-01106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/201403/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34806/25/2014
    Labeler - Mueller Sports Medicine LLC (006426316)
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