FDA Label for Simanix
View Indications, Usage & Precautions
Simanix Product Label
The following document was submitted to the FDA by the labeler of this product Home Aide Diagnostics, Inc.. 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.
Information For Patients
PURPOSE: Topical analgesic
ACTIVE INGREDIENTS
Capsaicin 0.0375% --------------------------------------------------------------------------------------------------- Counterirritant
Menthol 3% --------------------------------------------------------------------------------------------------------- Topical analgesic
Histamine DiHydrochloride0.035% ----------------------------------------------------------------------------------- Topical analgesic
Indications & Usage
INDICATIONS
For the temporary relief of minor pain of muscles and joints associated with:
- Arthritis
- Simple Backache
- Strains
- Sprains
- Bruises
- 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
DIRECTIONS
Store at 20°-25°C (68°-77 °F). Avoid direct sunlight.
Warnings And Precautions
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
- 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
STOP USE AND ASK A DOCTOR IF:
Other Safety Information
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 Ingredient
INACTIVE INGREDIENTS
aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose; odium; water
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