Label: PAIN-A-TRATE EXTRA STRENGTH PAIN-RELIEVING- camphor and menthol and methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 19, 2020

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  • ACTIVE INGREDIENT

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

  • 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

  • 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
  • ASK DOCTOR

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

  • WHEN USING

    When using this product

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

    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

    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

  • PRINCIPAL DISPLAY PANEL

    image of label
  • PRINCIPAL DISPLAY PANEL

    image of label
  • INGREDIENTS AND APPEARANCE
    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)
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