Label: RELIEF PAIN RELIEVING CREAM- menthol cream

  • NDC Code(s): 58559-002-01, 58559-002-02, 58559-002-03, 58559-002-04, view more
    58559-002-05
  • Packager: Corganics, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Menthol 3%

  • PURPOSE

    Counterirritant

  • USAGE

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

  • WARNINGS

    For external use only. Avoid contact with the eyes. If condition worsens, or if symptons persist for more than 7 days or clear up and occur again after a few days, discontinue use of this product and consult a physician.

    Do Not Use

    • on wounds or damaged skin
    • when bandaged tightly or with a heating pad
    • with other topical products
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS

    • Adults and children 2 years old and older: apply a small amount to affected area not more than 3 to 4 times daily.
    • Gently massage until absorbed.
    • Children under 2 years of age: consult a physician.
  • INACTIVE INGREDIENTS

    Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Caprylic/Capric Triglycerides, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Sweet Orange) Oil, Cymbopogon Martini (Palmarosa) Oil, Deionized Water, Eucalyptus Globulus Leaf Oil, Glycerine, L-Arginine Monohydrochloride, Lavandula Angustifolia (Lavender) Oil, Lecithin, Mentha Piperita (Peppermint Oil), Methylsulfonylmethane, Phenoxyethanol, Potassium Hydroxide, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    CONTAINER LABEL

  • INGREDIENTS AND APPEARANCE
    RELIEF PAIN RELIEVING CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58559-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARGININE (UNII: 94ZLA3W45F)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58559-002-015 g in 1 BLISTER PACK; Type 0: Not a Combination Product05/22/2004
    2NDC:58559-002-0282 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/22/2004
    3NDC:58559-002-03115 g in 1 TUBE; Type 0: Not a Combination Product05/22/2004
    4NDC:58559-002-04450 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/22/2004
    5NDC:58559-002-053600 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/22/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/22/2004
    Labeler - Corganics, LP (028162522)
    Establishment
    NameAddressID/FEIBusiness Operations
    JW Nutritional LLC017642837manufacture(58559-002)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!