PAIN BUST R II (MENTHOL, METHYL SALICYLATE) CREAM [CCA INDUSTRIES, INC.]

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PAIN BUST R II (MENTHOL, METHYL SALICYLATE) CREAM [CCA INDUSTRIES, INC.]
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NDC 61543-3130-3
Set ID 64c97569-0485-4136-8fe7-8be4babd8973
Category HUMAN OTC DRUG LABEL
Packager CCA Industries, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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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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