ZEN HEMP BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL, METHYL SALICYLATE) CREAM [ZEN ENTERPRISES LLC]

ZEN HEMP BALM (CAMPHOR, EUCALYPTUS OIL, MENTHOL, METHYL SALICYLATE) CREAM [ZEN ENTERPRISES LLC]
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NDC 73048-001-01
Set ID 85ba819e-830b-0c84-e053-2991aa0a5118
Category HUMAN OTC DRUG LABEL
Packager Zen Enterprises LLC
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

    Active Ingredients......................................Purpose

    Camphor 11%............................................Topical Analgesic

    Eucalyptus Oil 10%....................................Anti-Inflammatory

    Menthol 8%................................................Topical Analgesic

    Wintergreen Oil (Methyl Salicylate) 10%....Topical Analgesic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental ingestion.

    If swallowed, seek medical attention or consult a physician immediately.

  • INDICATIONS & USAGE

    Uses: Temporarily relieves minor aches & pains related to

    • headaches
    • backaches
    • joint and muscle pain
    • cramps and spasms
    • sprains and other sports related injuries
  • 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.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Narayani Oil, Clove Oil, Nutmeg Oil, Cassia Oil, Paraffin Wax, Cinnamon Oil, Peppermint Oil, White Petroleum Jelly, Borneol, Light Liquid Paraffin, Citronella Oil, Beeswax

  • WARNINGS

    CAUTIONS

    For external use only

    When using this product discontinue use if excessive irritation of the skin develops. Avoid contact wih eyes and mucous membranes, Do not bandage. Do not use with a 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 or
    • excessive skin irritation occurs

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ZEN HEMP BALM 
    camphor, eucalyptus oil, menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73048-001
    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) MENTHOL8 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)  
    CLOVE OIL (UNII: 578389D6D0)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    BORNEOL (UNII: M89NIB437X)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    HEMP (UNII: TD1MUT01Q7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73048-001-0120 g in 1 JAR; Type 0: Not a Combination Product04/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/22/2019
    Labeler - Zen Enterprises LLC (063099830)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.Sankunni's Ayurvedic Research Foundation Private Limited650517704manufacture(73048-001)

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