Label: THE QUEEN ROSE- witch hazel liquid

  • 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 February 20, 2013

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  • ACTIVE INGREDIENT

    Active ingredient: Witch Hazel 0.1%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    ANISE OIL, BERGAMOT OIL, CHAMOMILLE ROMAN OIL, GERANIUM OIL, LAVENDER OIL, LEMON OIL, ORANGE OIL, OLIVE OIL, ROSE BULGARIA OIL, YLANG YLANG OIL, SUN FLOWER OIL, LEONURUS SIBIRICUS EXTRACT, ANGELICA GIGAS ROOT EXTRACT, ARTEMISIA PRINCEPS LEAF EXTRACT, CHRYSANTHEMUM ZAWADSKII EXTRACT

  • PURPOSE

    Purpose: Skin Protectant, Fragrance

  • WARNINGS

    Warnings:
    In case of having following symptoms after using this, you're advised to stop using it immediately.
    If you keep using it, the symptoms will get worse and need to consult a dermatologist.
    1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
    2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
    You are banned to use it on the part where you have a scar, eczema, or dermatitis.
    In case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS AND USAGE

    Indication and usage:
    Tighten the lid after using it.
    Keep it out of infants or children's reach.
    Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration:
    Tighten the lid after using it.
    Keep it out of infants or children's reach.
    Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    THE QUEEN ROSE 
    witch hazel liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55885-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.005 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANISE OIL (UNII: 6Y89129C8H)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55885-010-015 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/01/2012
    Labeler - LaLa Co., Ltd. (688380004)
    Registrant - LaLa Co., Ltd. (688380004)
    Establishment
    NameAddressID/FEIBusiness Operations
    LaLa Co., Ltd.688380004manufacture(55885-010)
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