Label: ULTRA PAIN-A-TRATE PAIN-RELIEVING CREAM- camphor and menthol and methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 28, 2024

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  • ACTIVE INGREDIENT

    Active ingredients

    Camphor 4%

    Menthol 10%

    Methyl Salicylate 30%

  • PURPOSE

    Purpose

    Topical analgesic

  • INDICATIONS & USAGE

    Indications For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Provides penetrating relief.

  • 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
    • symptoms clear up and occur again within a few 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 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, deionized water, glyceryl monostearate SE, melaleuca alternifolia (tea tree) leaf oil, polysorbate 80, propanediol, steareth-2, steareth-21, stearic acid, triethanolamine

  • PRINCIPAL DISPLAY PANEL

    Tube

  • INGREDIENTS AND APPEARANCE
    ULTRA PAIN-A-TRATE  PAIN-RELIEVING CREAM
    camphor and menthol and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-334
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.4 g  in 85 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.5 g  in 85 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE25.5 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    STEARETH-2 (UNII: V56DFE46J5)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARETH-21 (UNII: 53J3F32P58)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-334-0385 g in 1 TUBE; Type 0: Not a Combination Product10/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)10/01/2021
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc079711683manufacture(54473-334)
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