Pain-a-trate
FDA Label NDC 54473-150

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Pain-a-trate (NDC 54473-150). 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, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients
Camphor 3.25%
Menthol, 1.5%
Methyl Salicylate, 15%

Otc - Purpose

Purpose
Topical analgesic

Indications & Usage

Uses for the temporary relief of minor aches and pains of muscles and joints. Provides penetrating pain relief of aches and pains associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

Warnings
For external use only

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor

Ask a doctor before use if you have redness over the affected area.

Otc - When Using

When using this product

  • avoid contact with eyes or mucus membranes
  • do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • excessive skin irritation occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • apply generously to affected area with gentle massage
  • do not apply more than 3 to 4 times daily

Storage And Handling

Other information do not store above 95°F (35°C)

Inactive Ingredient

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, benzyl alcohol, cetyl alcohol, deionized water, FD and C blue no. 1, FD and C yellow no. 5, glyceryl monostearate SE, Melaleuca Oil (T36-C5 ® brand), polysorbate 20, sorbitan stearate, steric acid, triethanolamine

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