Label: SPAI-SONS CALENDULA/MARIGOLD- calendula officinalis flower extract cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 25, 2012

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  • ACTIVE INGREDIENT

    SPAI-SONS MARIGOLD CREAM IS BASED IN CALENDULA OFFICINALIS EXTRACT

  • PURPOSE

    THE PRODUCT HAS BEEN DEVELOPED TO IMPLEMENT IN AREAS WHERE THIS FLASH, USEFUL IN WOUND HEALING PROCESS

  • KEEP OUT OF REACH OF CHILDREN

    THIS PRODUCT KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    THIS PRODUCTT MAY BE USED IN PEOPLE WHO DO NOT SUBMIT HYPERSENSITIVITY COMPONENTS, CAN BE USED AS A DAILY MOISTURIZING SKIN

  • WARNINGS

    AVOID IN TAKE OF PRODUCT, IF SO CHECK WITH YOUR DOCTOR

  • DOSAGE & ADMINISTRATION

    THE PRODUCT IS TOPICAL APPLICATION, APPLY THE AMOUNT NEEDED IN THE AREA DESIRED

  • INACTIVE INGREDIENT

    THE EXCIPIENTS CONTAINED IN THIS PRODCUT ARE PART OF A FORMULATION BASE ON A MOISTURIZER AND CONDITIONING THE SKIN, WHICH DOES NOT GENERATE IRRITATION, SO ITS USE IS NOT CONTRAINDICATED.
    ALSO CALENDULA OFFICINALIS EXTRACT HAS OTHER NATURAL EXTRACTS THAT HELP GIVE A BETTER FEELING IN THE SKIN.
  • PRINCIPAL DISPLAY PANEL

    IMAGE OF THE CARTON LABELIMAGE OF THE CARTON LABEL

  • INGREDIENTS AND APPEARANCE
    SPAI-SONS  CALENDULA/MARIGOLD
    calendula officinalis flower extract cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER20 g  in 100 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    CHAMOMILE (UNII: FGL3685T2X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorbrown (LIGTH BROWN) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-001-019 g in 1 JAR
    2NDC:66854-001-031 in 1 BOX
    2NDC:66854-001-0233 g in 1 JAR
    3NDC:66854-001-051 in 1 BOX
    3NDC:66854-001-0460 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/01/2004
    Labeler - SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Registrant - SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
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