MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [NUCARE PHARMACEUTICALS,INC.]

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MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [NUCARE PHARMACEUTICALS,INC.]
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NDC 68071-1617-3
Set ID 553fc7bd-0826-0730-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager NuCare Pharmaceuticals,Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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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)
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