FRANKIE AVALONS ZERO PAIN ROLL ON (CAPSAICIN) CREAM [FRANKIE AVALON'S VENUS LTD.]

FRANKIE AVALONS ZERO PAIN ROLL ON (CAPSAICIN) CREAM [FRANKIE AVALON'S VENUS LTD.]
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NDC 71480-831-00
Set ID 3c857c2c-e29f-4cb5-bd62-c47446e345ee
Category HUMAN OTC DRUG LABEL
Packager Frankie Avalon's Venus Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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.

  • 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.

  • SPL UNCLASSIFIED SECTION

  • 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), 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.

  • 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.
  • 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.

  • STORAGE AND HANDLING

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

  • Do not use if outside safety seal is broken or tampered with.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    FRANKIE AVALONS ZERO PAIN ROLL ON 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71480-831
    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)  
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71480-831-0090 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/08/2017
    Labeler - Frankie Avalon's Venus Ltd. (080673443)

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