Label: RUBBING DOTS NATURAL COOL PAIN RELIEF- menthol cream

  • NDC Code(s): 73294-005-04, 73294-005-28
  • Packager: Awesome Trading, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • DRUG FACTS:

  • Active Ingredient:

    Menthol 5.00%

    Topical Analgesic

  • Indications:

    For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

  • Warnings:

    For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children.

    If swallowed, consult physician.

    Do not apply to wounds or damaged skin.

    Do not bandage tightly.

    If pregnant or breast feeding, contact physician prior to use.

  • Directions:

    Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.

    Children under two-years of age: consult a physician.

  • Additional Information:

    Store at room temperature.

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, *Butyrospermum Parkii (Shea) Butter, *Calendula Officinalis Extract, Cetearyl Alcohol, Ethylhexylglycerin, *Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Alcohol, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid.

  • Package Labeling: 73294-005-28

    Label

  • Package Labeling: 73294-005-04

    Label1

    Tube

  • INGREDIENTS AND APPEARANCE
    RUBBING DOTS NATURAL COOL PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73294-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73294-005-283785 mL in 1 JAR; Type 0: Not a Combination Product05/21/2020
    2NDC:73294-005-04110 mL in 1 TUBE; Type 0: Not a Combination Product05/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/21/2020
    Labeler - Awesome Trading, LLC (117076974)
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