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Pain-A-Trate (Melaleuca, Inc.)

Available Formats

Dosage Form Package Information Links
CREAM 28 g in 1 TUBE (54473-150-01) Label Information
CREAM 85 g in 1 TUBE (54473-150-03) Label Information

Complete Pain-A-Trate Information

  • 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


  • INGREDIENTS AND APPEARANCE
    PAIN-A-TRATE  EXTRA STRENGTH PAIN-RELIEVING
    camphor and menthol and methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-150
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 32.5 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 15 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 150 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54473-150-03 85 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2018
    2 NDC:54473-150-01 28 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 05/01/2007
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    Name Address ID/FEI Business Operations
    Melaleuca, Inc 079711683 manufacture(54473-150)