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

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

Drug Labeling and Warnings

Drug Details

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PAIN-A-TRATE EXTRA STRENGTH PAIN-RELIEVING- camphor and menthol and methyl salicylate cream 
Melaleuca, Inc.

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.

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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

image of label

image of label
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)32.5 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TEA TREE OIL (UNII: VIF565UC2G)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER COPOLYMER TYPE B (UNII: 1G56KV7BUJ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54473-150-0385 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
2NDC: 54473-150-0128 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2007
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc079711683manufacture(54473-150)

Revised: 2/2018
 
Melaleuca, Inc.


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