Relispray Natural Pain Relief Aerosol, Spray
FDA Label NDC 46063-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Midas-care Pharmaceuticals, Pvt. Ltd for the product Relispray Natural Pain Relief (NDC 46063-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 4% w/w
Purpose
Topical analgesic
Uses
Relispray's unique formulation temporarily relieves minor pain associated with:
• Arthritis • Simple backache
• Muscle strains • Sprains
• Bruises • Cramps
Warnings
For external use only.
Flammable: Keep away from excessive heat or open flame. Do not store at temperature above 120°F.
Contents under pressure.
Do not puncture or Incinerate.
Ask a doctor before use if you have: Sensitive skin.
When using this product
• Use only as directed.
• Avoid contact with the eyes or on mucous membranes.
• Do not apply to wounds or damaged skin.
• Do not apply to irritated skin or if excessive irritation develops.
• Do not bandage.
• Do not use with heating pad or device.
Stop use and ask a doctor if
• You experience pain, swelling or blistering of the skin.
• Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
• Arthritic pain persists for more than 10 days, or redness is present
If pregnant or breast-feeding, ask a health professional before use.
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.
Directions
Adults and children 12 years of age & older: spray on to affected area not more than 3 to 4 times daily; massage not necessary.
Children under 12 years of age: consult a physician
Wash hands after use with cool water
Other Information
• Store at 20-50° C (68-77° F)
• Store in a cool dry place away from direct sunlight.
Inactive Ingredients
Camphor, Cinnamon Oil, Clove Oil, Eucalyptus Oil, Isopropyl Alcohol, Propellant, Methyl Salicylate, Propylene Glycol, Turpentine Oil
Packaging
Relispray Natural Pain Relief (46063101 1)
* Please review the disclaimer below.
