Label: CAMPO PHARMA MUSCLE HOT- capsaicin cream

  • 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 January 16, 2023

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  • Drug Facts

  • Active Ingredients

    Capsaicin 0.050%

    Purpose

    Counterrirriant

  • 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: 

    External use only

    • In case of accidental ingestion, seek professional asistance 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 few days, discontinue use, and consult a doctor. 

    Keep this and oil drugs out of the reach of children.

  • Directions:

    • This product is a storng counterirritant. Apply sparingly. Adults and children 6 years of age older: apply to affected area nor more thna 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 it 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 ingredient:

    Mineral Oil, Paraffin, Petrolatum

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    CAMPO PHARMA MUSCLE HOT 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82777-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82777-001-01397 g in 1 JAR; Type 0: Not a Combination Product09/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2022
    Labeler - Latin Shots, Inc (080681098)
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