Label: ULTRA PAIN-A-TRATE PAIN-RELIEVING CREAM- 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 January 30, 2023

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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 not finalpart34810/01/2021
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc079711683manufacture(54473-334)
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