Label: ORIGINAL 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 11, 2023

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  • ACTIVE INGREDIENT

    Active ingredients

    Camphor 3.25%

    Menthol, 1.5%

    Methyl Salicylate, 15%

  • 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, sprains. Provides penetrating pain 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, aloe barbadensis flower extract, benzyl alcohol, cetyl alcohol, chlorophyllin-copper complex, coccinia indica fruit extract, corallina officianalis extract, curcuma longa (turmeric) root extract, ethylhexylglyverin, glyceryl monostearate SE, melaleuca alternifolia (tea tree) leaf oil, melia azadirachta flower extract, melia azadirachta leaf extract, ocimum basilicum (basil) flower/leaf extract, ocimum sanctum (holy basil) leaf extract, polysorbate 20, solanum melongena (eggplant) fruit extract, sorbitan stearate, stearic acid, triethanolamine, water

  • PRINCIPAL DISPLAY PANEL

    Pain-A-Trate Original Tube 3oz

  • INGREDIENTS AND APPEARANCE
    ORIGINAL PAIN-A-TRATE  PAIN-RELIEVING CREAM
    camphor and menthol and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-335
    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
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
    OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)  
    OCIMUM GRATISSIMUM LEAF OIL (UNII: AVG2506KDV)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM COPPER CHLOROPHYLLIN A (UNII: VAC44EX123)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    SOLANUM MELONGENA WHOLE (UNII: 5DS5EE0N93)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-335-0385 g in 1 TUBE; Type 0: Not a Combination Product10/01/2021
    Image of Product
    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(54473-335)
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