Label: FRANKIE AVALONS ZERO PAIN ORIGINAL FORMULA ROLL-ON MAXIMUM STRENGTH PAIN RELIEVER - capsaicin liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

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

  • Frankie Avalon's ZERO PAIN Original Formula Roll-On Maximum Strength PAIN RELIEVER
  • Active Ingredient

    Capsaicin 0.025%

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  • Purpose

    External Analgesic

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  • Uses:

    Temporarily relieves minor aches and pains of muscles and joint due to

    • arthritis
    • strains
    • sprains
    • bursitis
    • sports injuries
    • bruises
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  • Warnings:

    • For external use only
    • Use Only as Directed
    • Avoid contact with eyes or mucous membranes
    • Do not apply to wounds or damaged skin
    • Do not bandage tightly
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  • Stop use and ask your doctor if:

    • Condition worsens
    • Excessive irritation or blistering of the skin develops
    • Pain persists for more than 7 days
    • Symptoms clear up and occur again within a few days
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  • Keep out of Reach of Children

    If swallowed get immediate medical help or contact a Poison Control Center immediately.

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  • 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's skin sensitivity and usually decreases or disappears after continued use. Product may be removed from the test area by wiping with rubbing alcohol. Before use read other important information inside box.

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  • OTHER INGREDIENTS:

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

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  • Questions or comments

    call 877-581-1502 or visit www.americanretailalliance.com

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  • Frankie Avalon's ZERO PAIN Original Formula Roll-On Maximum Strength PAIN RELIEVER

    "Hello everyone Frankie Avalon here and if you have suffered with pain like I have you are going to love my original formula that has sold millions of units and is still helping countless individuals with chronic arthritis pain. I'm not a pain expert but I am an expert in dealing with pain Try Zero Pain and see what it can do for you!"

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    Frankie Avalon Zero Pain is a registered trademark of Frankie Avalon's Venus, LTD
    Exclusively distributed by:
    American Retails Alliance Corp.
    Belleair Bluffs, FL 33770

    Topical Analgesic

    Doctor Recommended Formula

    Easy to apply
    Roll-On Applicator

    For the temporary relief of muscle aches and pains associated with

    Arthritis Bursitis Simple Back Ache Sports Injury Bruises

    Non-Greasy/Non-Staining Odorless

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  • Directions:

    Adults and children 10 years of age and older:  Apply to affected area not more than 3 to 4 times daily.  Children under 10 years of age:  consult a doctor.

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  • PRINCIPAL DISPLAY PANEL

    Frankie Avalon's ZERO PAIN Original Formula Roll-On Maximum Strength PAIN RELIEVER
    Net Wt. 3 fl oz (90ml)

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  • Frankie Avalon's ZERO PAIN Original Formula Roll-On Maximum Strength PAIN RELIEVER 3oz/90ml (65121-496-04)
  • INGREDIENTS AND APPEARANCE
    FRANKIE AVALONS ZERO PAIN ORIGINAL FORMULA ROLL-ON MAXIMUM STRENGTH PAIN RELIEVER 
    capsaicin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65121-496
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (CAPSAICIN) CAPSAICIN 0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    WATER  
    INDIAN FRANKINCENSE  
    C13-14 ISOPARAFFIN  
    DMDM HYDANTOIN  
    GOLDENSEAL  
    ISOPROPYL ALCOHOL  
    LAURETH-7  
    ALFALFA  
    POLYSORBATE 20  
    YUCCA SCHIDIGERA  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65121-496-04 1 in 1 BOX
    1 90 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 07/10/2013
    Labeler - Pure Source Inc. (969241041)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source Inc. 969241041 manufacture(65121-496)
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