ZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]

ZIKS ARTHRITIS PAIN RELIEF CREAM [NNODUM PHARMACEUTICALS]
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NDC 63044-030-60
Set ID 5dd4fefc-b70a-4850-819c-1cca6f28aa97
Category HUMAN OTC DRUG LABEL
Packager Nnodum Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART334
  • ACTIVE INGREDIENTS:

    Methyl Salicylate 12%, Menthol 1% and Capsaicin 0.025%

  • INACTIVE INGREDIENTS:

    Cetyl Alcohol, Ceteth-2, Sorbitol Solution, Imidazolidinyl Urea and Purified Water.

  • INDICATIONS:

    For the temporary relief of minor aches and pain of muscles and joints associated with arthritis, simple backache, strains and sprains. *Products containing purified capsaicin are most recommended by doctors and pharmacists.

  • 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 physician. A passing burning sensation may occur upon application, but generally disappears in several days. Application schedules of less than 3 to 4 times a day may not provide optimum pain relief ant the burning sensation may persist. WASH HANDS WITH SOAP AND WATER AFTER APPLYING UNLESS TREATING HANDS.

  • WARNING:

    For external use only. Avoid contact with eyes and mucus membranes. If conditions 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 physician. Do not apply to wounds, damage or broken (open), irritated skin or excessive irritation develops.

    Do not bandage tightly. Do not use with heating pad. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

    Storage

    Store at room temperature 15-30 degrees C (59-86 degrees F). Lot number and expiration date: See tube seal area or end flap.

  • How Supplied:

    Ziks cream is supplied in a 2 oz. tube.

    Distributed by: ZIKS Healthcare Products, Cincinnati, OH 45229

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ZIKS ARTHRITIS PAIN RELIEF 
    ziks arthritis pain relief cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63044-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE6.79 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.566 mg  in 1 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.014 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETETH-20 (UNII: I835H2IHHX)  
    SORBITOL (UNII: 506T60A25R)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63044-030-6056.6 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33411/10/1999
    Labeler - Nnodum Pharmaceuticals (960457273)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alliance Packaging Group031754588MANUFACTURE