Label: RED HOT- capsaicin ointment

  • NDC Code(s): 59316-996-21, 59316-996-96
  • Packager: Performance Health, LLC
  • 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 August 7, 2022

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  • Drug Facts

  • Active Ingredients

    Capsaicin 0.050%

    Purpose

    Counterirritant

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, tendonitis, simple backache, and arthritis, Combined with stretching and calisthenics, Red Hot assists in the warm-up process, especially in cool, damp weather.

  • Warnings

    For external use only.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Use only as directed. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor.

    Keep this and all drugs out of reach of children.

  • Directions

    This product is a strong counterirritant. Apply sparingly. Adults and children 6 years of age and older: apply to affected area not more than 3-4 times daily. Children under 6 years of age: consult a doctor.

  • Other Information

    This product is intended to and will cause mild skin irritation. Discontinue use if excessive irritation of skin develops. Avoid getting into eyes or on mucous membranes. Do not apply to irritated or broken skin. Store in a cool, dry place with lid closed tightly.

  • Inactive Ingredients

    Mineral Oil, Paraffin, Petrolatum

  • Questions?

    (800) 345-2231 

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    RED HOT 
    capsaicin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-996
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-996-2178 g in 1 TUBE; Type 0: Not a Combination Product05/19/201712/31/2024
    2NDC:59316-996-96454 g in 1 BOTTLE; Type 0: Not a Combination Product05/19/201712/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/19/201712/31/2024
    Labeler - Performance Health, LLC (794324061)
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