Label: DREAM CREAM- camphor, menthol cream

  • NDC Code(s): 70722-232-02
  • Packager: Little Moon Essentials
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 30, 2020

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  • Drug Facts

  • Active Ingredients

    Camphor 0.45%

    Menthol 5%

  • Purpose

    Topical Analgesic

  • Uses

    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 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 apply to wounds or damages, broken or 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 afew 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 chidren over 12 years:

    • Apply a thin layer to affected area
    • Massage into painful area until thoroughly absorbed into skin repeat as necessary, but no moore than 3to 4 times daily, allowing 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 68-77º​F (20-25ºC)

    Protect from excessive moisture

  • Inactive Ingredients

    Water (aqua)

    organic safflower oil (cathamus tictorius)

    beeswax (cera alba)

    cetearyl olivate

    arnica oil (arnica montana)

    castor oil (ricinus communis)

    cetearyl alcohol

    wintergreen oil (gaultheria procumbens)

    xanthan gum

    cinnamon oil (cinnamomum zeylanicum)

    lavender oil (lavendula angustifolia)

    cyprus oil (cupressus sempervirens)

    eucalytus blue mallee oil

    marjorm (thymus mastichina)

    rosemary oil (rosmarinus officinalis)

    juniper oil (juniperus communis)

    magnesium aluminum silicate

    immortelle oil (helichrysum angustifolium)

    clary sage oil (salvia sclarea)

    tea tree oil (melaleuca alternifolia)

    peppermint oil (mentha piperita)

    basil oil (ocimum basilicum)

    ginger (zingiber officinale)

    benzoin (styrax benzoin resin extract)

    potassium sorbate

    sodium benzoate

  • Principle Display Panel 56.7 g container

    2oz Dream Cream

  • 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
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.45 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    SWEET MARJORAM (UNII: G9Z40ZYU6P)  
    GINGER (UNII: C5529G5JPQ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)  
    EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PSEUDOGNAPHALIUM LUTEOALBUM WHOLE (UNII: HR514FFZ7I)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    BASIL OIL (UNII: Z129UMU8LE)  
    BENZOIN RESIN (UNII: GK21SBA74R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70722-232-0256.7 g in 1 CONTAINER; Type 0: Not a Combination Product10/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/04/2016
    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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