WOMENS SPORTS BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL, METHYL SALICYLATE) CREAM [DR.SANKUNNI'S AYURVEDIC RESEARCH FOUNDATION PRIVATE LIMITED]

WOMENS SPORTS BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL, METHYL SALICYLATE) CREAM [DR.SANKUNNI'S AYURVEDIC RESEARCH FOUNDATION PRIVATE LIMITED]
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NDC 70146-003-00, 70146-003-01, 70146-003-02
Set ID 928e421d-2a62-463a-a5ad-ce412654dc8f
Category HUMAN OTC DRUG LABEL
Packager Dr.Sankunni's Ayurvedic Research Foundation Private Limited
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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