Label: PURE RELIEF- capsaicin cream

  • NDC Code(s): 64058-356-34
  • Packager: Concept Laboratories, Inc.
  • 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 27, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

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  • Purpose

    Pain Relieving

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  • Uses

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

    • simple backache
    • arthritis
    • strains
    • sprains
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  • Warnings

    For external use only.

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

    When using this product avoid eye contact

    • avoid contact with mucous membranes

    Stop use and ask a doctor if condition worsens

    • if symptoms persist for more than 7 days
    • 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
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  • Directions

    • for adults only
    • apply a thin layer to affected area not more than 4 times daily
    • gently massage into the skin until fully absorbed
    • wash hands with soap and water after each application to avoid spreading to sensitive mucous membranes
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  • Other information

    • Excess product can be removed with a soft cloth and cooking oil.
    • If applying product to hands, wait 30 minutes before washing.
    • Avoid water, heat, or direct sunlight while using product.
    • If wearing contact lenses, insert prior to application and avoid touching them after applying product.
    • If eye contact occurs, flush immediately with water.
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  • 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.

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  • SPL UNCLASSIFIED SECTION

    Manufactured by Concept Laboratories, Inc.
    Chicago, IL 60642 (USA) www.conceptlabs.org
    #CL9783-R2

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  • PRINCIPAL DISPLAY PANEL - 113 g Jar Label

    EFFECTIVE RELIEF

    PURE RELIEF™
    PAIN RELIEVING CREAM

    WITH MOISTURIZING ALOE,
    EMU OIL & GLUCOSAMINE

    NET WT. 4 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Jar Label
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  • INGREDIENTS AND APPEARANCE
    PURE RELIEF 
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-356
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin 2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALFALFA (UNII: DJO934BRBD)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
    ROSEMARY (UNII: IJ67X351P9)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    GINKGO (UNII: 19FUJ2C58T)  
    FLAX SEED (UNII: 4110YT348C)  
    CELOSIA ARGENTEA SEED (UNII: O1H314U8M2)  
    ACAI (UNII: 46AM2VJ0AW)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EMU OIL (UNII: 344821WD61)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    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)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64058-356-34 113 g in 1 JAR; Type 0: Not a Combination Product 12/06/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 12/06/2016
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    Name Address ID/FEI Business Operations
    Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-356)
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