MAGICAL MUSCLE OIL (CAMPHOR, MENTHOL) OIL [LITTLE MOON ESSENTIALS]

MAGICAL MUSCLE OIL (CAMPHOR, MENTHOL) OIL [LITTLE MOON ESSENTIALS]
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NDC 70722-246-04
Set ID 3d87fdc4-6adf-1d73-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Little Moon Essentials
Generic Name
Product Class
Product Number
Application Number PART348
  • Drug Facts

  • Active Ingredients

    Camphor 1.95%

    Menthol 3.75%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor in associated with

    • ​Simple backache
    • Muscle strains
    • Sprains
    • Bruises
  • Warning

    For external use only

    When using this product

    • Use only as directed
    • Read and follow all directions and warnings of this label
    • Rare cases of serious burn have been reported with products of this type
    • Do not bandage tightly or apply local heat (such as heating pads) or medicated patches to the area of use
    • Avoid contact with eyes and mucous membranes
    • Do not apply to wounds or damaged, broken or irritated skin
    • A trasient burning sensation my occur upon application but generally dissapears in several days
  • Stop use and ask a doctor

    • Conditions worsens
    • Redness is present
    • Irritation develops
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • You experience signs of skin injury, such as pain, swelling or blistering where the product was applied
  • If pregnant or breast feeding

    Ask a health professional before use

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Adults and children over 12 years:

    • ​Apply a thin layer to affected are
    • Massage into painful area until thoroughly absorbed into skin
    • Repeat as necessary, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications
    • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

    ​​Children 12 years or younger: ​Ask a doctor

  • Other information

    Store at 68-77ºF (20-25º​C)

    Protect from excessive moisture

  • Inactive Ingredients

    Organic Sesame oil ( Sesamun Indicum)

    Organic Olive oil ( Olea Eruropaea)

    Organic Cayenne Powder ( Capsicum Frutescens)

    Organic Ginger powder (Zingiber Officinale)

    Organic Castor oil (Ricinus Communis)

    Wintergreen oil (Gaultheria Procumbens)

    Cinnamom oil ( Cinnamomum zeylanicum)

    Lavender oil (Lavendula Angustifolia)

    Clary sage oil (Salvia sclarea)

    Marjoram oil (Thymus mastichina)

    Basil oil ( Ocinum basilicum)

    Cardamon oil (Elettaria cardamomum)

    Ginger oil (Zingiber officinale)

  • Principal Display Panel- 4 oz (118ml) bottle

    4 oz Magical Muscle Oil

  • INGREDIENTS AND APPEARANCE
    MAGICAL MUSCLE OIL 
    camphor, menthol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70722-246
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.75 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1.95 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GINGER (UNII: C5529G5JPQ)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    RED PEPPER (UNII: 6M47G7C4SY)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SWEET MARJORAM OIL (UNII: ICH7BE016E)  
    BASIL OIL (UNII: Z129UMU8LE)  
    CARDAMOM OIL (UNII: JM0KJ091HZ)  
    SESAME OIL (UNII: QX10HYY4QV)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70722-246-04113.4 g in 1 BOTTLE; Type 0: Not a Combination Product09/27/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/27/2016
    Labeler - Little Moon Essentials (840835115)
    Registrant - Little Moon Essentials (840835115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Little Moon Essentials840835115manufacture(70722-246)

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