Label: MUSCLE AND JOINT PAIN RELIEF- menthol, methyl salicylate cream

  • NDC Code(s): 53943-991-04
  • Packager: Discount Drug Mart, Inc.
  • 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 November 9, 2015

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  • Active ingredients

    Menthol 10%

    Methyl salicylate 15%

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  • Uses

    temporarily relieves the minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
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  • Warnings

    For external use only

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • If you are allergic any of the ingredients
    • on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if you have

    redness over the affected area.

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

    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 to avoid accidental ingestion.

    If swallowed, get medical help or contact a Poison Control Center immediately.

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  • Directions

    • use only as directed
    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
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  • Other information

    • store at 20° to 25°C (68° to 77°F)
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  • Inactive ingredients

    carbomer 940, cetyl alcohol, glycerin, glycerol monostearate, isoprophyl myristate, methylparaben, PEG 15 glyceryl stearate, propylparaben, purified water, stearic acid, stearyl alcohol, trolamine

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  • Purpose

    Topical analgesic

    Topical analgesic

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  • Package label

    Discount Drug Mart Greaseless Muscle Rub

    muscle.greaseless.carton

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  • INGREDIENTS AND APPEARANCE
    MUSCLE AND JOINT PAIN RELIEF 
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-991
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-15 GLYCERYL STEARATE (UNII: 91245SPD5K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53943-991-04 1 in 1 BOX
    1 114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/09/2015
    Labeler - Discount Drug Mart, Inc. (047741335)
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