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

MAGICAL MUSCLE OIL (CAMPHOR, MENTHOL) OIL [LITTLE MOON ESSENTIALS]
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NDC 70722-246-02
Set ID 3d726fd6-ed05-1c12-e054-00144ff88e88
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 pain 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 on this label
    • Rare cases of serious burn have been reported with product 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 or mucous membranes
    • Do not apply to wounds or damaged, broken or irritated skin
    • A transient burning sensation may occur upon application but generally disappears in several days
  • Stop use and ask a doctor if

    • Condition worsens
    • Redness is present
    • Irritation develop
    • 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 12 years:

    • ​Apply a thin layer to affected area
    • 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 (20-25ºC).

    Protect from excessive moisture.

  • Inactive Ingredients

    Organic Sesame Oil (Sesamum Indicum)

    Organic Olive Oil (Olea Europaea)

    Organic Cayenne Powder (Capsicum Frutescens)

    Organic Ginger Powder (Zingiber Officinale)

    Organic Castor Oil (Ricinus Communis)

    Wintergreen Oil (Gaultheria Procumbens)

    Cinnamom Oil (Cinnamomun Zeylanicum)

    Lavender Oil (Lavandula Angustifolia)

    Clary Sage Oil (Salvia Sclarea)

    Marjoram Oil (Thymus Mastichina)

    Basil Oil (Ocimum Basilicum)

    Cardamom Oil (Elettaria Cardamomum)

    Ginger Oil (Zingiber Officinale)

  • Principle Display Panel 2oz (59ml) - bottle

    2 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
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1.95 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM3.75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SESAME OIL (UNII: QX10HYY4QV)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    RED PEPPER (UNII: 6M47G7C4SY)  
    GINGER (UNII: C5529G5JPQ)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    SWEET MARJORAM OIL (UNII: ICH7BE016E)  
    BASIL OIL (UNII: Z129UMU8LE)  
    CARDAMOM OIL (UNII: JM0KJ091HZ)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70722-246-0256.7 g in 1 BOTTLE; Type 0: Not a Combination Product09/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/26/2016
    Labeler - Little Moon Essentials (840835115)
    Registrant - Little Moon Essentials (840835115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Little Moon Essentials840835115manufacture(70722-246)

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