Label: SPAI-SONS MARIGOLD OILY SKIN- sulfur 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 June 7, 2012

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  • ACTIVE INGREDIENT

    Marigold extracts of medicinal plants, bio-sulfur and a selection of natural assets for the treatment of some skin rashes.

  • PURPOSE

    For treatment of some skin rashes that do not participate in the pathogenic microorganisms, particularly the treatment of acne.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Due to its composition Marigold cream is very active to normalize oily skin, hyper-secretory, body rashes, burns, or as an accelerator of wound healing, its greatest virtue is the design as an adjunct in the treatment of acne.

  • WARNINGS

    Avoid the contact with eyes. suspend its use if you notice an unfavorable reaction on the skin.

  • DOSAGE & ADMINISTRATION

    Apply a sufficient amount and gently spread with fingertips until the skin absorbs it. This product is for topical application

  • INACTIVE INGREDIENT

    The formula includes extracts of medicinal plants and bio-sulfur, a trace element essential to cellular organization, is an asset which splits fats and regulates the secretion of the sebaceous glands, act synergistically other extracts such as healing, anti-inflamatory, antiseptic, antipuritic dermal, refreshing and soothing.

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF THE LABEL IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    SPAI-SONS   MARIGOLD OILY SKIN
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66854-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.1 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)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 85 (UNII: A7F3N56197)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    GINGER (UNII: C5529G5JPQ)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    DIMETHICONE PEG-7 ISOSTEARATE (UNII: JVS3399FNW)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66854-023-019 g in 1 JAR
    2NDC:66854-023-0233 g in 1 JAR
    3NDC:66854-023-0360 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/30/2012
    Labeler - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)
    Establishment
    NameAddressID/FEIBusiness Operations
    SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS880172184analysis, label, manufacture, pack
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