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

  • NDC Code(s): 53554-010-03, 53554-010-05, 53554-010-10
  • Packager: AMRUTANJAN HEALTH CARE LIMITED
  • 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 November 15, 2019

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

  • AMRUTANJAN RELIEF PAIN BALM Active ingredients

    Camphor 10.0%

    Menthol 8.0%

    Methyl Salicylate 14.0%

  • Purpose

    Camphor                           Topical analgesic

    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 add 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 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 doctor
  • Other Information

    Store at room temperature

  • Inactive ingredients

    butylated hydroxy toluene, cinnamon leaf oil, citronella oil, clove oil, east indian lemongrass oil, eucalyptus oil, light mineral oil, microcrystalline wax, paraffin, petrolatum, quinoline yellow (D&C yellow no.11).

  • Questions?

    Call 1-888-611-6811

  • PRINCIPAL DISPLAY PANEL - 30 g Jar Carton                                               NDC 53554-010-05 AMRUTANJANRELIEFPAIN BALMTM PAIN RELIEVING OINTMENT NET WT: 1.05 OZ (30g)

    PRINCIPAL DISPLAY PANEL - 30 g Jar Carton

    30 g JAR CARTON LABEL

  • INGREDIENTS AND APPEARANCE
    AMRUTANJAN RELIEF PAIN BALM 
    camphor , menthol, methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53554-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.1 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.08 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.14 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    CLOVE OIL (UNII: 578389D6D0)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53554-010-051 in 1 CARTON06/29/2015
    130 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:53554-010-101 in 1 CARTON06/29/2015
    250 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:53554-010-031 in 1 BLISTER PACK06/29/2015
    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(53554-010)