FDA Label for Topical Analgesic
View Indications, Usage & Precautions
Topical Analgesic Product Label
The following document was submitted to the FDA by the labeler of this product Dermaline Usa Corp. 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 Ingredient(S)
Methyl Salicylate 15% . Purpose: Topical Analgesic
Purpose
Topical Analgesic
Use
For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Warnings
For external use only. Avoid Contact with the eyes. Do not bandage tightly or apply to wounds or damaged costs.
Do Not Use
- On children under 16 years of age except on the advice of the physician.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Pregnancy
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case accidental ingestion, get medical help or contact a Poision Control Center right away.
Directions
Adults and children 16 years of age and older: Wash the affected area with mild soap and warm water and rinse thoroughly. Apply to affected area not more than 3 to 4 times daily.
Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age; consult a doctor.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat
Inactive Ingredients
Arnica, camphor, eucalyptus oil, D&C brown #486. Menthol, Mineral Oil, Paraffin Wax, Propylparaben, Tea Tree Oil, White Petrolatum
Otc - Stop Use
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days.
Package Label - Principal Display Panel
2.5oz
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