Active Ingredients Purpose
Camphor 11%...................................................Topical analgesic
Menthol 11%....................................................Topical analgesic
Pain Relief Balm Ointment
FDA Label NDC 73492-718
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alaina Healthcare Private Limited for the product Pain Relief Balm (NDC 73492-718). 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 active ingredients purpose, uses, warnings, when using this product, stop use and ask a doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, strains and sprains
Warnings
For external use only
When Using This Product
- use only as directed
- avoid contact with eyes & mucous membranes
- do not apply to wounds, damaged, or irritated skin
- do not bandage or cover with wrap or use heating pad
- do not use 1 hour prior to bathing or within 30 minutes after bathing
Stop Use And Ask A Doctor If
- condition worsens
- severe skin irritation occurs
- pain persists for more than 7 days
- pain clears up & then recurs a few days later
Directions
Adults and children 12 years of age and older | Apply to affected area not more than 3 to 4 times daily |
Children under 12 years of age | Consult a doctor before use |
Children under 2 years of age | Do not use |
Other Information
- This product may cause allergic reaction on some individuals. Test on a small area before use.
- Do not use if printed seal is broken or missing
- Recommended storage temperature below 86°F (30°C). Store in a cool, dry place.
Inactive Ingredients
Cajuput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil, Paraffin Base
Questions?
Call XXX-XXX-XXXX
Principal Display Panel
Pain Relief Balm Ointment 0.5 oz (14.2g) - NDC 73492-718-15 - Container Label
Image Description (Pain Relief Balm Ointment Container Label)
Pain Relief Balm Ointment 0.5 oz (14.2g) - NDC 73492-718-15 - Carton Label
Image Description (Pain Relief Balm Ointment Carton Label)
* Please review the disclaimer below.
