Otc - Active Ingredient
Active ingredients Purpose
Methol 4%.......................................................Topical analgesic
Methyl salicylate 1%.........................................Topical analgesic
Coralite Pain Relief Stick
FDA Label NDC 65923-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Coralite Pain Relief Stick (NDC 65923-120). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
For temporary relief of minor muscle and joint discomfort associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
Warnings
For external use only. If pregnant or breast-feeding, ask a health professional before use.
Allergy Alert: Do not use if allergic to salicylates (including aspirin) without consulting a physician.
Otc - When Using
When using this product use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes and mucous membranes, do not apply to wounds or damaged skin.
Otc - Stop Use
Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, redness is present or irritation develops.
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.
Indications & Usage
Directions
Adults and Children 10 Years of Age and Older
- Apply generously to affected area
- Massage into area until thoroughly absorbed into skin
- Repeat as necessary, but no more than 4 times daily
Childreun Under 10 Years of Age Consult a doctor
Storage And Handling
Other information
- Store at 20° to 25°C (68° to 77°F)
Inactive Ingredient
Inactive ingredients ethyl alcohol, hydrogenated castor oil, PEG-150 distearate, propylene glycol, sodium stearate, water
Dosage & Administration
Distributed by:
United Exchange Corp.
17211 Valley View Ave.
Cerritos, CA 90703 USA
Toll Free: 1 800 814 8028
Made in China
Package Label.Principal Display Panel
Image Description (90120)
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