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Pain-A-Trate Extra Strength Pain-Relieving

Dosage form: cream
Ingredients: CAMPHOR (SYNTHETIC) 32.5mg in 1g, MENTHOL 15mg in 1g, METHYL SALICYLATE 150mg in 1g
Labeler: Melaleuca, Inc.
NDC Code: 54473-150

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Pain-A-Trate Extra Strength Pain-Relieving Cream Content of Label

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

Purpose
Topical analgesic

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
For external use only

Do not use

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

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

When using this product

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

Stop use and ask a doctor if

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

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

Directions

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

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

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

PAIN-A-TRATE   EXTRA STRENGTH PAIN-RELIEVING
camphor and menthol and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-150
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)32.5 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL15 mg  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glyceryl monostearate 
Stearic Acid 
Cetyl Alcohol 
Sorbitan monostearate 
Polysorbate 20 
Tea Tree Oil 
Trolamine 
Carbomer Copolymer Type B 
Benzyl Alcohol 
FD&C Blue No. 1 
FD&C Yellow No. 5 
Packaging
#Item CodePackage Description
1NDC:54473-150-0385 g in 1 TUBE
2NDC:54473-150-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2007
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIOperations
Melaleuca, Inc139760102manufacture

Revised: 09/2010
 
Melaleuca, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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