Label: AMRUTANJAN RELIEF STRONG PAIN BALM- menthol, methyl salicylate ointment

  • NDC Code(s): 53554-020-03, 53554-020-05, 53554-020-10
  • Packager: AMRUTANJAN HEALTH CARE LIMITED
  • 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 November 15, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients

    Menthol 15.0%

    Methyl Salicylate  15%

  • Purpose

    Menthol                    Topical analgesic

    Methyl Salicylate      Topical analgesic

  • Uses

    • Temporarily relieves pain associated with headache, cold, body ache and nasal congestion
    • Provides temporary relief of minor pains of muscles and joints
  • Warnings

    For External use only

    • Avoid contact with eyes
    • Do not use otherwise than as directed
  • When using this product

    • Do not heat
    • Do not microwave
    • Do not use near an open flame
    • Do not add to hot water or any container where heating water. May cause splattering and result in burns
    • Avoid contact with wounds, mucous membranes, broken or irritated skin
    • Do not bandage tightly or use with heating pad
  • Stop use of this product and consult a doctor if

    • Condition worsens
    • Redness or irritation develops
    • Symptoms persist for more than 7 days or clear up and occur again within a few days or is accompanied by fever, rash, or persistent headaches

  • If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare personal before use

  • Keep out of reach of children, if swallowed, get medical help or contact a poison control center right away

  • Directions

    • See important warning "When using this product"
    • Adults and children over 12 years
    • Apply and gently massage over the affected area
    • Repeat 2- 3 times daily, or as directed by a doctor
    • Children 12 years or younger: ask a doctor
  • Other Information

    Store at room temperature

  • Inactive ingredients

    butylated hydroxy toluene, cetostreayl alcohol, microcrystalline wax, paraffin, petrolatum

  • Questions?

    Call 1-888-611-6811

  • NDC 53554-020-05AMRUTANJAN RELIEF Strong PAIN BALMTM PAIN RELIEVING OINTMENTNET WT: 1.05 OZ (30g)

    PRINCIPAL DISPLAY PANEL - 30 g Jar Carton

    image description

  • INGREDIENTS AND APPEARANCE
    AMRUTANJAN RELIEF STRONG PAIN BALM 
    menthol, methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53554-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.15 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53554-020-051 in 1 CARTON08/12/2015
    130 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:53554-020-101 in 1 CARTON08/12/2015
    250 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:53554-020-031 in 1 BLISTER PACK08/12/2015
    39 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/23/2015
    Labeler - AMRUTANJAN HEALTH CARE LIMITED (650128309)
    Registrant - AMRUTANJAN HEALTH CARE LIMITED (650128309)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAKSON INDUSTRIES PRIVATE LIMITED650553980manufacture(53554-020)