Label: QR PAIN- analgesic cream

  • NDC Code(s): 73180-005-00, 73180-005-01
  • Packager: MARYHELENE ENTERPRISES INC
  • 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 January 10, 2023

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  • DRUG FACTS

  • Active Ingredient

    Mannitol 30%

    Menthol 1.25%

  • Purpose

    Topical Analgesic

  • Uses

    for the temporary relief of pain.

  • Warnings

    For external use only.

  • When using this product

    • do not bandage tightly
    • avoid contact with the eyes
    • do not apply to wounds or damaged skin
    • do not use with heating pads or other heating devices
    • as with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product
    • do not use in large quantities, particularly over raw surfaces or blistered areas.
  • Stop use and ask a doctor if

    Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • Keep out of reach of children

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

  • Directions

    Adults and children 12 years of age and older, apply to affected area no more than 3-4 times a day. Children under 12 years of age: do not use, contact a doctor.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    Lecithin, Ethylhexylglycerin, Ceteareth 20, Glyceryl stearate, Octyldodecanol, Phenoxyethanol, Propylene glycol, Isopropyl Palmitate, Caprylic/Capric triglyceride, Dimethicone, Polyethylene glycol 100 stearate, Water, Cetearyl alcohol.

  • Questions or Comments?

    1-833-772-7326 (1 833 QR CREAM) or visit www.qrcream.com

  • QR PAIN CREAM 5g (NDC 73180-005-00)

    QR Cream 5g

  • INGREDIENTS AND APPEARANCE
    QR PAIN 
    analgesic cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73180-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A) MANNITOL30 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73180-005-011 in 1 BOX12/01/2019
    1NDC:73180-005-005 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2019
    Labeler - MARYHELENE ENTERPRISES INC (203935056)
    Registrant - MARYHELENE ENTERPRISES INC (203935056)
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