Label: WOMENS RELIEF BALM- camphor, eucalyptus oil, menthol, methyl salicylate cream

  • NDC Code(s): 70146-001-00, 70146-001-01
  • Packager: Dr.Sankunni's Ayurvedic Research Foundation Private 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 June 4, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients   Purpose

    Camphor 11%                                           Topical Analgesic

    Eucalyptus Oil 10%                                    Anti-Inflammatory

    Menthol 8%                                               Topical Analgesic

    Wintergreen Oil (Methyl Salicylate) 10%     Topical Analgesic

  • PURPOSE

    Uses:  Temporarily relieves minor aches & pains related to

    • arthritis
    • backaches
    • bursitis
    • sore muscles
    • joint pain
    • leg cramps
    • bruises
    • sprains
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental ingestion.

    If swallowed, get medical help or contact a poison control center immediately.

  • INDICATIONS & USAGE

    ZEN

    for aches & pains

    women's relief balm jasmine oil

    ideal for:

    aches & pains related to

    rheumatoid arthritis

    joint pain

    backaches

    bursitis

    sore muscles

    arthritis

    leg cramps

    sprains and strains

  • DOSAGE & ADMINISTRATION

    Directions:

    • use only as directed
    • apply generously to affected area 3 to 4 times daily
    • children under 12, consult a doctor before use.
  • WARNINGS

    WARNINGS For external use only

    When using this product

    • discontinue use if excessive irritation of the skin develops
    • avoid contact with eyes and mucus membranes
    • do not bandage tightly
    • do not use with heating pad

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
  • INACTIVE INGREDIENT

    Inactive Ingredients

    paraffin wax, white petroleum jelly, light liquid paraffin, beeswax, clove oil, nutmeg oil, cassia oil, cinnamon oil, peppermint oil, borneol, citronella oil, jasmine oil

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    WOMENS RELIEF BALM 
    camphor, eucalyptus oil, menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70146-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)11 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL10 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CLOVE OIL (UNII: 578389D6D0)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    BORNEOL (UNII: M89NIB437X)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70146-001-005 g in 1 JAR; Type 0: Not a Combination Product10/19/201501/19/2016
    2NDC:70146-001-015 g in 1 JAR; Type 0: Not a Combination Product01/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/15/2015
    Labeler - Dr.Sankunni's Ayurvedic Research Foundation Private Limited (650517704)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.Sankunni's Ayurvedic Research Foundation Private Limited650517704manufacture(70146-001)
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