Label: MIRAE SKIN- witch hazel soap

  • 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 December 19, 2018

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  • Active Ingredient

    Active ingredient: WITCH HAZEL 0.1%

  • Inactive Ingredients

    Inactive ingredients:
    Aqua (Purified Water), Saponin, Linoleic Acid, Sodium Hydroxide, Carbohydrate, Quercetin, Flavonoid, Oleic Acid, Kaolin, Sodium, Vitamin B1, dietary fiber, Vitamin B2, Protein, Lauric Acid, Zinc Oxide, Ascorbic Acid, Allantoin, Myristic Acid, Vitamin E, Caprylic Acid, Decanoil Acetaldehyde, Palmitic Acid, Colloidal Oatmeal

  • Purpose

    Purpose: Atopy, Dry Skin, Moisture, Itching, Pimple and Skin-Care

  • Warnings

    Warnings:
    Due to the nature of natural soap this products can be dissolved in water and moisture to escape, so please keep note.
    Because production process have all been accomplished by hand-made, Net weights and colors may be different from others slightly.

  • Keep out of reach of children

    Keep out of reach of children:
    Keep out of reach of babies and children.

  • Uses

    Indication and usage:
    1. After face washing and bathing, to remove moisture.
    2. Firstly fine bubbles out with SKIN soap and put them on the entire face with soft massage.
    3. When bubbles under the skin was left little you should sum up with foundation makeup.

  • Directions

    Dosage and administration:
    At least once in 24 hours to use.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MIRAE SKIN 
    witch hazel soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43071-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.15 g  in 150 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43071-100-01150 g in 1 CARTON; Type 0: Not a Combination Product07/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/01/2011
    Labeler - HUMAN AND NATURE (557816137)
    Registrant - HUMAN AND NATURE (557816137)
    Establishment
    NameAddressID/FEIBusiness Operations
    HUMAN AND NATURE557816137manufacture(43071-100)
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