ZIKS ARTHRITIS PAIN RELIEF cream

ZIKS ARTHRITIS PAIN RELIEF by

Drug Labeling and Warnings

ZIKS ARTHRITIS PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Nnodum Pharmaceuticals, Contract Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ZIKS ARTHRITIS PAIN RELIEF 
ziks arthritis pain relief cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63044-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	6.79 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.566 mg  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.014 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
CETETH-20 (UNII: I835H2IHHX)
SORBITOL (UNII: 506T60A25R)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63044-030-60	56.6 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part334	11/10/1999

Labeler - Nnodum Pharmaceuticals (960457273)

Establishment
Name	Address	ID/FEI	Business Operations
Alliance Packaging Group		031754588	MANUFACTURE