Label: FRANKIE AVALONS ZERO PAIN ROLL ON- capsaicin cream

  • NDC Code(s): 71480-831-00
  • Packager: Frankie Avalon's Venus Ltd.
  • 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 9, 2017

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

  • DRUG FACTS:
  • Active Ingredient

    Capsaicin 0.025%

    External Analgesic

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  • USES:

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

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  • 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.

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  • 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.

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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 and usually decreases or disappears after continued use. Read all information on the box and the opposite panel before use.

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  • OTHER INGREDIENTS:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Boswellia 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 Extrat.

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  • For External Use Only
  • Keep Out of Reach of Children

    • Use only as directed
    • If swallowed get medical attention or contact a poison control center immediately.
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  • How to apply:

    Apply to a small area of the skin first as a test for sensitivity for at least 60 minutes before applying to a larger area.  If discomfort persists after application, cotton swab area with rubbing alcohol.

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  • STORAGE AND HANDLING

    Store between 59 0-86 0F (15 0-30 0C)

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  • Do not use if outside safety seal is broken or tampered with.
  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    FRANKIE AVALONS ZERO PAIN ROLL ON 
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71480-831
    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 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    BLACK COHOSH (UNII: K73E24S6X9)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ALFALFA (UNII: DJO934BRBD)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71480-831-00 90 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 06/08/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/08/2017
    Labeler - Frankie Avalon's Venus Ltd. (080673443)
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