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  5. Label Information: Pain-a-trate Extra Strength Pain-relieving

FDA Label for Pain-a-trate Extra Strength Pain-relieving

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT

Pain-a-trate Extra Strength Pain-relieving Product Label

The following document was submitted to the FDA by the labeler of this product Melaleuca, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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