Label: MUSCLE RUB 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 December 26, 2020

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  • Active Ingredient

    Active IngredientUse
    Menthol 3.5%Topical Analgesic

  • Uses

    Uses:

    • For temporary relief of minor aches and pains. Used for muscle and joint pain associated with arthritis, backache, strains, sprains
  • Do Not Use

    Do not use:

    • On wounds or damaged skin
    • With a heating pad
    • On children under 12 years of age
    • If pregnant or breast feeding
  • Stop use and ask a physicinan if:

    Stop use and ask a physician if:

    • Conditiion worsens or symtops persist for more than 7 days
    • Symptoms clear up and occur again within a few days
    • Excessive skin irritation occurs
  • Directions

    Directions
    Use only as directed
    Adults and children 12 years of age and older, rub a thin layer to affected area 3-4 times daily
    Children under 12 years of age consult a physician
    Wash hands after applying

  • Storage

    Store at 68-86 degrees with lid tightly closed

  • Inactive Ingredient

    Alcohol Denaturated, Camphor, Carbomer, Ethylhexylglycerin, Glycerin, Jaanese Green tea ( Camellia Sinesis) Extract, Laureth-4, Petrolatum, Pineapple (Ananas Sativus) Extract, Polysorbate 80, Propylene Glycol, Phenoxyethanol, Triethanolamine, Water

  • Warnings For External Use Only:


    Warnings For External Use Only:

    • Avoid contact with eyes and mucous membranes. Do not bandage tightly
  • Distributed By

    Distributed by: MedZone

    Lenexa, Kansas

    Ph 913-948-9663

    www.medzonecorp.com

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

  • PRINCIPAL DISPLAY PANEL

    Muscle Rub

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB 
    muscle rub cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-652
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LAURETH-4 (UNII: 6HQ855798J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70338-652-0185 g in 1 TUBE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2019
    Labeler - MEDZONE PRODUCTS LLC (080083739)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dhaliwal Pharmaceuticals Laboratories LLC116933772manufacture(70338-652)
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