Label: FRANKIE AVALONS ZERO PAIN ROLL-ON PAIN RELIEVER- capsaicin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 17, 2024

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  • DRUG FACTS:

  • Active Ingredient

    Capsaicin 0.025%

    External Analgesic

  • USES:

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

  • WARNINGS:

    For external use only. Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly.

    Keep Out of Reach of Children

  • DIRECTIONS:

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

  • OTHER INFORMATION:

    Products containing capsaicin may cause a burning, stinging or tingling sensation where applied. This is a natural reaction and varies with each individual and usually decreases or disappears after continued use. Read all information on the box and the opposite panel before use.

  • OTHER INGREDIENTS:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Extract, Boswella Serrata Extract, C13-14 Isoparaffin, Chamomilla Recutitta (Chamomile) Extract, Cimicifuga Racemosa (Black Cohosh) Extract, DMDM Hydantoin, Glycerin, Hydrastis Canadensis (Goldenseal) Root Extract, Isopropyl Alcohol, Laureth-7, Medicago Sativa (Alfalfa) Extract, Polyacrylamide, Polysorbate-20, Yucca Schidegera Extract. 

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    FRANKIE AVALONS ZERO PAIN ROLL-ON PAIN RELIEVER 
    capsaicin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84413-481
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CHAMOMILE (UNII: FGL3685T2X)  
    BLACK COHOSH (UNII: K73E24S6X9)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    YUCCA SCHIDIGERA WHOLE (UNII: 08A0YG3VIC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84413-481-0090 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/06/2024
    Labeler - WHY ENTERPRISES LLC (012392823)