Label: PAIN BUST R II- menthol, 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 22, 2019

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  • Drug Facts

  • Active Ingredients

    Menthol 12.00%

    Methyl Salicylate 17.00%

    Purpose

    Topical Analgesic

  • Use

    Temporarily relieves minor pain associated with arthritis

  • Warnings

    For external use only

    Allergy alert: Do not use if you are allergic to salicylates (including aspirin) unless directed by a doctor.

    When using this product

    • Use only as directed
    • Do not bandage tightly or use a heating pad
    • Avoid contact with eyes or mucous membranes
    • Do not apply to wounds or damaged skin

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • Redness is present
    • Irritation develops

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children over 17 years apply generously to affected area; massage into painful area until thoroughly absorbed into skin; repeat as necessary but no more than 4 times daily
    children 17 years or youngerdo not use without asking a doctor

  • Inactive Ingredients

    Ceteth-2, Cetyl Alcohol, DEA-Cetyl Phosphate, Emulsifying Wax, Glyceryl Stearate SE, PEG-40 Stearate, Stearic Acid, Stearyl Alcohol, Water (Aqua).

  • Other Information

    Store in a cool palce

  • Questions or comments?

    Call 1-800-595-6230

    Report any issues associated with this product to the telephone number or address listed on this package.

  • Package Labeling:

    OuterPackage1OuterPackage2OuterPackage3OuterPackage4OuterPackage5PainBustRTube

  • INGREDIENTS AND APPEARANCE
    PAIN BUST R II 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-3130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE17 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-2 (UNII: 7H8VAM7778)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-3130-31 in 1 CARTON12/23/2011
    185 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/23/2011
    Labeler - CCA Industries, Inc. (106771041)
    Establishment
    NameAddressID/FEIBusiness Operations
    Suite K Value Added Services LLC036822144manufacture(61543-3130)
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