Label: OUTBACK PAIN RELIEF- camphor 6%, menthol 16% cream

  • NDC Code(s): 72839-987-02
  • Packager: Derma Care Research Labs, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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  • ACTIVE INGREDIENT

    Camphor 6%, Menthol 16%

  • PURPOSE


    Topical Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.

  • WARNINGS

    For external use only. When using this product use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes or mucous membranes, and do not apply to wounds or damaged skin. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding ask a health professional.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older apply generously to the affected area not more than 4 times daily. Children under 12 years of age: ask a doctor.

  • INACTIVE INGREDIENT

    Benzyl Alcohol, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polyacrylamide, Sorbitan Olivate, Tocopherol, Vanilla Planifolia Fruit Extract, Water.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    OUTBACK PAIN RELIEF 
    camphor 6%, menthol 16% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-987
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)6 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VANILLA BEAN (UNII: Q74T35078H)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-987-0257 g in 1 TUBE; Type 0: Not a Combination Product05/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/13/2021
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-987)
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