Label: RELEXO OIL- menthol, camphor oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 April 19, 2017

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

  • Relexo Massage oil Active Ingredients

    Menthol             10%

    Camphor             5%

  • Purpose

    Natural support for healthy joints

  • Uses

    Temporary relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • Inactive Ingredients

    Mustard oil, Linseed oil, Wintergreen oil, Ajowa oil, Boswelia oil, Mustard oil processed with Castor, Drum stick, Thorn apple, Cissus quandragularis

  • Direction for use

    Gently massage the oil over the affected body parts or as directed by physician.

  • Warnings

    • Do not apply on an open wound or to exposed skin
    • If you are pregnant or breast-feeding, consult your healthcare professional before use
    • If condition gets worse or skin irritation occurs, stop usage and consult your doctor
  • Keep out of children's reach 

  • Other Information

    Apply on samll area of skin to test any allergic reactions before using.

    (*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.)

  • BAPS AMRUTRelexo Massage oil

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  • INGREDIENTS AND APPEARANCE
    RELEXO OIL 
    menthol, camphor oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57631-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5   in 1 mL
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)2.5   in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MUSTARD OIL (UNII: TYY1MA9BSY)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    CISSUS QUADRANGULARIS WHOLE (UNII: 3VMW64U790)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57631-116-111 in 1 CARTON06/14/2017
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/28/2017
    Labeler - InvaTech Pharma Solutions LLC (078602180)
    Registrant - InvaTech Pharma Solutions LLC (078602180)
    Establishment
    NameAddressID/FEIBusiness Operations
    InvaTech Pharma Solutions LLC078602180relabel(57631-116)
    Establishment
    NameAddressID/FEIBusiness Operations
    BAPS Swaminarayan Herbal Care,A Unit of Divine Energy921183294manufacture(57631-116) , analysis(57631-116) , pack(57631-116)