Active Ingredients
Methyl Salicylate 50 mg
L-Methenol 80 mg
Pain Goodbye Aqueous Patch
FDA Label NDC 15667-7396
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Austin Biotechnology Inc for the product Pain Goodbye Aqueous Patch (NDC 15667-7396). 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, stop use and ask a doctor if, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Methyl Salucylate External Analgesic
L-Methenol External Analgesic
Uses
Uses for the temporary relief of minor aches, and points of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Warnings
For External Use Only. Do not use on wounds, on infected or damaged skin.
For children under 12 years of age, do not use, consult a doctor.
Stop Use And Ask A Doctor If
Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or consult a poison control center right away.
Condition worsens.
Symptom clears up and occurs again within a few days.
Symptom persists for more than 7 days.
Nausea, vomitting, abdominal discomfort, diarrhea, or skin rash occurs.
Excessive irritation of the skin develops.
Avoid contact with eyes or mucous membranes.
Do not bandage tightly.
When using for pain of arthritis:
In conditions affecting children under 12 years of age
If red nose is present
If pain persists for more than 10 days
Directions
Adult and children 12 years of age and older; Remove the clear film backing and apply to the sore area of skin. Use not than 3 times daily.
Bandage will remain effective after 24 hours and will be even more effective when using after a bath.
Do not apply to extremely hairy skin. Highly adhesive bandage may hurt skin upon removal.
Other Information:
Keep container tightly closed. Once opened, fold the opening and keep pressed. Close with a clip.
Store at room temperature.
Inactive Ingredients
Gelatin, Myrrhm, Sesame Oil, Water and Zinc Oxide
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