MACOMA SENIOR PREMIUM CLEANSER (ALLANTOIN) GEL [PARMA KOREA.CO.LTD]

MACOMA SENIOR PREMIUM CLEANSER (ALLANTOIN) GEL [PARMA KOREA.CO.LTD]
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NDC 71614-001-01, 71614-001-02
Set ID c85de446-0850-42bd-82fa-b02d3f9757ed
Category HUMAN OTC DRUG LABEL
Packager PARMA KOREA.CO.LTD
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Allantoin 1%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Body Cleansing

  • DOSAGE & ADMINISTRATION

    Push out adequate amount of MACOMA Cleanser and apply it on shower towel or hands. Make fluent bubble scrub and massage from hair to body and wash out with warm water.

  • WARNINGS

    Consult with dermatologiest when there is any symptom such as erythema, swelling, irritation and esnsitization.

    Immediately wash off when it is in mouth or eyes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INACTIVE INGREDIENT

    Water
    Lauramidopropyl Betaine
    Hyaluronic Acid
    Sodium Cocoamphoacetate
    Methyl Hydroxyethylcellulose
    Acetyl Hexapeptide-8
    Disodium EDTA
    Lauryl Glucoside
    Betula Alba Juice
    Olea Europaea (Olive) Fruit Extract
    Hydrolyzed Collagen
    Trehalose
    Centella Asiatica Extract
    Butylene Glycol
    Diglycerin
    Oryza Sativa (Rice) Bran Extract
    Hamamelis Virginiana (Witch Hazel) Extract
    Bambusa Vulgaris Extract
    Curcuma Longa (Turmeric) Root Extract
    Artemisia Vulgaris Extract
    Arctium Lappa Root Extract
    Hippophae Rhamnoides Extract
    Rheum Palmatum Root Extract
    Eucalyptus Globulus Leaf Extract
    Citrus Aurantium Bergamia (Bergamot) Fruit Extract
    Lavandula Angustifolia (Lavender) Flower Extract
    Sapindus Mukorossi Fruit Extract
    Pelargonium Graveolens Extract
    Panax Ginseng Root Extract
    Mentha Piperita (Peppermint) Extract
    Propolis Extract
    Mandelic Acid
    Tocopheryl Acetate
    Ascorbic Acid
    Polysorbate 85
    1,2-Hexanediol
    Caprylic/Capric Triglyceride


  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MACOMA SENIOR PREMIUM CLEANSER 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71614-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    HYMETELLOSE (50 MPA.S) (UNII: 0MGW7Q3QG4)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    BETULA PUBESCENS RESIN (UNII: 9G931M6I4G)  
    BLACK OLIVE (UNII: 2M6QWV94OC)  
    TREHALOSE (UNII: B8WCK70T7I)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIGLYCERIN (UNII: 3YC120743U)  
    RICE BRAN (UNII: R60QEP13IC)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    TURMERIC (UNII: 856YO1Z64F)  
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    MANDELIC ACID (UNII: NH496X0UJX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    POLYSORBATE 85 (UNII: A7F3N56197)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71614-001-021 in 1 CARTON08/27/2018
    1NDC:71614-001-01660 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/27/2018
    Labeler - PARMA KOREA.CO.LTD (694857393)
    Registrant - PARMA KOREA.CO.LTD (694857393)
    Establishment
    NameAddressID/FEIBusiness Operations
    PARMA KOREA.CO.LTD694857393manufacture(71614-001)

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