DREAM CREAM (CAMPHOR, MENTHOL) CREAM [LITTLE MOON ESSENTIALS]

DREAM CREAM (CAMPHOR, MENTHOL) CREAM [LITTLE MOON ESSENTIALS]
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NDC 70722-232-04
Set ID 3e2765bc-7839-597d-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 0.45%

    Menthol 5%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves minor pain associated with

    • Simple backache
    • Muscle strains
    • Strains
    • Bruises
  • Warnings

    For external using this product

    • Use only as irected
    • ​Read and follow all directions and warningson 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 the area of use
    • Avoid contact with eyes and mucous membranes
    • Do not aply to wounds or damaged, broken irritated skin
    • A trasient burning sensation may occur upon application but generally dissapears 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 aea 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

    Water (aqua)

    Organic safflower oil (cathamus tinctorius)

    Beeswax (cera alba)

    Cetearyl olivate

    Arnica oil (arnica montana)

    Castor oil (ricinus communis)

    Cetearyl alcohol

    Wintergreen oil (gaultheria procumbens)

    Xanthan gum

    Cinnamom oil (Cinnamomum zeylanicum)

    Lavender oil (lavendula angustifolia)

    Cyprus oil ( cupressus sempervirens)

    Eucalyptus blue mallee oil

    Marjoram (thymus mastichina)

    Rosemary oil (rosmarinus officinalis)

    Juniper oil (juniperus communis)

    magnesium aluminum silicate

    Immortelle oil (helichysum angustifolium)

    Clary sage oil (salvia sclarea)

    Tea tree oil (melaleuca alternifolia)

    Peppermint oil (mentha piperita)

    Basil oi (ocimum basilicum)

    ginger (zingiber officinale)

    Benzoin (styrax benzoin resin extract )

    Potassium sorbate

    Sodium benzoate

  • Principle Display Panel 113g container

    4 oz Dream Cream.4 oz Vital Vapor Fold 2.4 oz Vital Vapor Fold 1.

  • INGREDIENTS AND APPEARANCE
    DREAM CREAM 
    camphor, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70722-232
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.45 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SWEET MARJORAM (UNII: G9Z40ZYU6P)  
    STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GINGER (UNII: C5529G5JPQ)  
    WATER (UNII: 059QF0KO0R)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)  
    EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    JUNIPERUS OXYCEDRUS LEAF OIL (UNII: YNW2QPG8YK)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PSEUDOGNAPHALIUM LUTEOALBUM WHOLE (UNII: HR514FFZ7I)  
    CLARY SAGE (UNII: U3HSK5JC0Q)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    BASIL OIL (UNII: Z129UMU8LE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70722-232-04113 g in 1 CONTAINER; Type 0: Not a Combination Product10/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/05/2016
    Labeler - Little Moon Essentials (840835115)
    Registrant - Little Moon Essentials LLC (840835115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Little Moon Essentials LLC840835115manufacture(70722-232)

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