VITAL VAPOR (CAMPHOR, MENTHOL) OINTMENT [LITTLE MOON ESSENTIALS]

VITAL VAPOR (CAMPHOR, MENTHOL) OINTMENT [LITTLE MOON ESSENTIALS]
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NDC 70722-229-05
Set ID 3deaead4-b9a0-4eda-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 0.6%

    Menthol 5.2%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor pain associated with

    • simple backache
    • muscle strains
    • sprains
    • bruises
  • Warning

    For exteral use only

    When using this product

    • ​use only as directed. Read and follow all directions and warnings on this label
    • rare cases of serious burns have been reported with products of this type
    • do not bandage tightly or apply local heat (such as heating pads) or medicated patches to teh 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 may occur upon application but generally disappears in several days
  • Stop use and ask a doctor

    • ​condition 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 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 ginger powder (zingiber officinale)

    organic castor oil (ricinus communis)

    beeswax (cera alba)

    eucaliptus staigeriana

    tea tree oil (melaleuca alternifolia)

    wintergreen oil (gaultheria procumbens)

    eucalyptus globulus oil

    lemongrass oil (cymbopogon citratus)

    lavender oil (lavandula angustifolia)

    nutmeg oil (myristica fragrans)

    ravensara oil (ravensara aromatic)

    sage oil (salvia officinalis)

  • Principle Display Panel 14g container

    0.5 oz Vital Vapor Bottom0.5 Vital Vapor Front..

  • INGREDIENTS AND APPEARANCE
    VITAL VAPOR 
    camphor, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70722-229
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5.2 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    SAGE OIL (UNII: U27K0H1H2O)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CRYPTOCARYA AGATHOPHYLLA LEAF OIL (UNII: XM00Z00H98)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GINGER (UNII: C5529G5JPQ)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    SESAME OIL (UNII: QX10HYY4QV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70722-229-0514 g in 1 CONTAINER; Type 0: Not a Combination Product10/02/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/02/2016
    Labeler - Little Moon Essentials (840835115)
    Registrant - Little Moon Essentials LLC (840835115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Little Moon Essentials LLC840835115manufacture(70722-229)

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