Label: MUSCLE RUB- menthol, methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL

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 October 17, 2019

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  • Active ingredients

    Menthol 10%

    Methyl salicylate 15%

  • Purpose

    Topical analgesic

  • Uses

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

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

    For external use only

    Do not use

    • other than as directed
    • on children under 12 years of age
    • with a heating pad (may blister skin)

    When using this product

    • avoid contact with the eyes or mucous membranes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask a doctor if

    • skin redness or excessive irritation of the skin develops
    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

    Keep out of reach of children

    to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults & 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: consult a physician
  • Other information

    • store at 20°-25°C (68°-77°F)
    • Lot No. & Exp. Date, see crimp of tube and see box
  • Inactive ingredients

    citric acid, glyceryl monostearate, lanolin, methylparaben, propylene glycol, propylparaben, purified water, stearic acid, trolamine

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    PDP

  • INGREDIENTS AND APPEARANCE
    MUSCLE RUB 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-1617(NDC:45802-174)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-1617-385 g in 1 BOX; Type 0: Not a Combination Product07/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/03/2011
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare pharmaceuticals,Inc.010632300relabel(68071-1617)