Label: AMRUT BALM- menthol, camphor ointment

  • Category: HUMAN OTC DRUG LABEL

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 June 23, 2017

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  • BAPS AMRUT BALM Active Ingredeints 

    Menthol               15%

    Camphor              3%

  • Purpose 

    Menthol            Topical analgesic

    Camphor           Topical analgesic

  • Uses

    Useful in Body Aches & Strains

    Long Lasting Effect
    Fast Acting 

  • Inactive Ingredients 

    • Clove oil
    • Turpin oil
    • Wintergreen oil
    • Eucalyptus oil
    • Cinnamon oil
    • Peppermint oil
    • Nutmeg oil
  • Directions for use

    Apply and rub generously on the affected area until it is absorbed. Repeat if necessary

  • Warnings

    For external use only

    • 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 REACH OF CHILDREN

    Keep out of children's reach

  • Other Information 

    Apply on small 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 AMRUT BALM0.8 OZ (25 g)

    image description

  • INGREDIENTS AND APPEARANCE
    AMRUT BALM 
    menthol, camphor ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57631-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.7 g  in 1 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.75 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CLOVE OIL (UNII: 578389D6D0)  
    TURNIP-ROOTED CHERVIL OIL (UNII: XKS0X2W3DK)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57631-105-081 in 1 CARTON06/14/2017
    125 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/18/2017
    Labeler - InvaTech Pharma Solutions LLC (078602180)
    Registrant - InvaTech Pharma Solutions LLC (078602180)
    Establishment
    NameAddressID/FEIBusiness Operations
    InvaTech Pharma Solutions LLC078602180label(57631-105)
    Establishment
    NameAddressID/FEIBusiness Operations
    BAPS Swaminarayan Herbal Care,A Unit of Divine Energy921183294manufacture(57631-105) , analysis(57631-105) , pack(57631-105)
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