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

  • NDC Code(s): 70146-003-00, 70146-003-01, 70146-003-02
  • Packager: Dr.Sankunni's Ayurvedic Research Foundation Private 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 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 in muscles and joints related to

    • strains
    • menstrual cramps
    • mild migraines
    • sprains
    • bruises
    • backaches
    • arthritis
    • sports and other minor injuries
  • 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 sports balm lavender oil

    ideal for:

    aches & pains related to

    sports injuries

    minor arthritis

    sore muscles

    leg cramps

    cramps

    strains and sprains

  • 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, narayani oil, clove oil, nutmeg oil, cassia oil, cinnamon oil, peppermint oil, borneol, citronella oil, lavender oil

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    WOMENS SPORTS BALM 
    camphor, eucalyptus oil, menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70146-003
    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
    PARAFFIN (UNII: I9O0E3H2ZE)  
    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)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70146-003-0020 g in 1 JAR; Type 0: Not a Combination Product10/19/2015
    2NDC:70146-003-015 g in 1 JAR; Type 0: Not a Combination Product01/18/2016
    3NDC:70146-003-025 g in 1 JAR; Type 0: Not a Combination Product01/18/201601/19/2016
    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(70146-003)
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