Label: HURT BLOCKER PRO PAIN RELIEF- capsaicin cream

  • NDC Code(s): 64058-246-42, 64058-246-64
  • 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 June 23, 2015

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
    • bruises
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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, pack, wrap, hot water bottle or any heating element

    When using this product do not get into eyes

    • avoid contact with other mucous membranes

    Flammable: Keep from heat and flame.

    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
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  • 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
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  • Inactive ingredients

    Water (Aqua), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Acrylates Copolymer, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

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  • Questions or comments?

    Call 1-888-373-8831

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  • PRINCIPAL DISPLAY PANEL - 106 g Bottle Label

    HURT
    BLOCKER
    PRO

    PAIN RELIEF

    SUPER HEAT
    CAPSAICIN
    & PEPPERMINT
    TINGLE

    OMEGAS 3, 6 & 9

    ACAI

    & ICE PEARLS

    NET WT 3.75 OZ. (106 g)

    PRINCIPAL DISPLAY PANEL - 106 g Bottle Label
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  • INGREDIENTS AND APPEARANCE
    HURT BLOCKER PRO   PAIN RELIEF
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-246
    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)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    ACAI OIL (UNII: Z0W6766A2W)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64058-246-42 57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:64058-246-64 106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 05/12/2015
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    Name Address ID/FEI Business Operations
    Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-246)
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