Simanix
FDA Label NDC 69379-013

PURPOSE: Topical analgesic

ACTIVE INGREDIENTS
Capsaicin 0.0357% --------------------------------------------------------------------------------------------------- Counterirritant
Menthol 3% --------------------------------------------------------------------------------------------------------- Topical analgesic
Histamine DiHydrochloride% ----------------------------------------------------------------------------------- Topical analgesic

INDICATIONS
For the temporary relief of minor pain of muscles and joints associated with:

• Arthritis
• Simple Backache
• Strains
• Sprains
• Bruises

DIRECTIONS

• Adults and children over 18 years:
• Apply generously to affected area
• Massage into painful area until thoroughly absorbed into skin
• Repeat as necessary, not more than 3-4 times daily.
• Wash hands with soap and water immediately after use.
• Children 18 years or younger: ask a doctor

Store at 20°-25°C (68°-77 °F). Avoid direct sunlight.

WARNINGS
FOR EXTERNAL USE ONLY.

• Use only as directed
• Do not bandage tightly
• Do not use with a heating pad
• Avoid contact with the eyes or mucous membranes
• Do not apply to wounds, damaged, broken or irritated skin
• A transient burning sensation may occur upon application but generally disappears in several days
• If severe burning sensation occurs, discontinue use immediately and call a doctor
• Do not expose the area treated with product to heat or direct sunlight

STOP USE AND ASK A DOCTOR IF:

• Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
• Redness is present or irritation develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

If pregnant of breast-feeding, ask a healthcare professional before use

INACTIVE INGREDIENTS
aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose; odium; water