Label: CAMELLIA CLEANSING BALM- mineral salve

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 7, 2016

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  • ACTIVE INGREDIENT

    Mineral Oil

  • INACTIVE INGREDIENT

    Butylene Glycol, 1,2-Hexandiol, Etc.

  • PURPOSE

    Cleansing, Moisturizing, Anti-aging

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    1. Scoop up the cleansing balm with spatula
    2. Gently rub and massage dry face with the cleansing balm
    3. Wash off with warm water
  • WARNINGS

    1. Do not use in the following cases(Eczema and scalp wounds)
    2.Side Effects
    1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
    3.General Precautions
    1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
    2)This product is for exeternal use only. Do not use for internal use
    4.Storage and handling precautions
    1)If possible, avoid direct sunlight and store in cool and area of low humidity
    2)In order to maintain the quality of the product and avoid misuse
    3)Avoid placing the product near fire and store out in reach of children

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CAMELLIA CLEANSING BALM 
    mineral salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71077-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL54.0999 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71077-0003-180 mL in 1 JAR; Type 0: Not a Combination Product11/07/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/07/2016
    Labeler - TOV Co., ltd (689851609)
    Registrant - TOV Co., ltd (689851609)
    Establishment
    NameAddressID/FEIBusiness Operations
    TOV Co., ltd689851609manufacture(71077-0003)