FDA Label for Ziks Arthritis Pain Relief
View Indications, Usage & Precautions
Ziks Arthritis Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Nnodum Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
* Please review the disclaimer below.