Label: NATURELIEF (wintergreen oil- methyl salicylate, eucalyptus oil, menthol, camphor gel

  • NDC Code(s): 84859-111-25
  • Packager: Novamed Healthcare Private Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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  • Dosage and Administration

    Apply generously to affected area 3 to 4 time daily

    Children under 12 consult a doctor before use.

  • Indication and Usage

    • Back pain & Muscle Spasms result due to strain, fatigue & stress
    • USES: Temporarily relieves minor aches & pains related to arthritis, headache, backache, joint and muscle pain, cramps and spasms sprains and other injuries
  • Inactive Ingredients

    Liquid Paraffin, Sodium Lauryl Sulphate, Carbomers BP, Simulgel 600, Sodium Hydroxide

  • Active Ingredients

    Wintergreen Oil (Methyl Salicylate) 20%

    Eucalyptus Oil 3%

    Menthol 2.5%

    Camphor 3%

  • Keep out of the reach of children

    Keep out of the reach of children

  • Stop use

    Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days

  • Purpose

    Active Ingredient Purpose

    Wintergreen Oil (Methyl Salicylate) 20% ...................Topical Analgesic

    Eucalyptus Oil 3% ......................................................Anti-Inflammatory

    Menthol 2.5% .............................................................Topical Analgesic

    Camphor 3% ..............................................................Topical Analgesic

  • Storage

    Store in a cool, dry place between 68 -77 F.

  • Warning

    For external use only.

  • WHEN USING

    When using this product

    • Discontinue use if excessive irritation of the skin develops.
    • Avoid contact with eyes and mucous membranes.
    • Do not bandage.
    • Do not use with a heating pad.
  • PRINCIPAL DISPLAY PANEL

    Naturelief

  • INGREDIENTS AND APPEARANCE
    NATURELIEF 
    wintergreen oil (methyl salicylate), eucalyptus oil, menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84859-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GAULTHERIA PROCUMBENS TOP (UNII: 830295X963) (GAULTHERIA PROCUMBENS TOP - UNII:830295X963) GAULTHERIA PROCUMBENS TOP5 g  in 25 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.75 g  in 25 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.75 g  in 25 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.625 g  in 25 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 0.01 g  in 25 g
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.355 g  in 25 g
    WATER (UNII: 059QF0KO0R) 16.244 mL  in 25 g
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.347 g  in 25 g
    PARAFFINUM LIQUIDUM (UNII: T5L8T28FGP) 0.7163 g  in 25 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84859-111-2525 g in 1 BOX; Type 0: Not a Combination Product12/16/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/16/2024
    Labeler - Novamed Healthcare Private Limited (645814547)
    Registrant - Novamed Healthcare Private Limited (645814547)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novamed Healthcare Private Limited645814547manufacture(84859-111) , label(84859-111) , pack(84859-111)
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