Label: RHUBARB BACTERIOSTATIC CREAM- jialunfuhe yellow jade paste paste

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

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Drug Label Information

Updated April 15, 2020

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  • SPL UNCLASSIFIED SECTION

    Rhubarb bacteriostatic cream

  • Active Ingredient(s)

    rhubarb 1g/20g
    icorice 2g/20g
    ginseng 5g/20g

  • Purpose

    Scope of application: burns, mechanical wounds and other wounds, the skin bacteria infection caused by staphylococcus aureus. It has antibacterial and bacteriostatic effects.

  • Use

    Scope of application: burns, mechanical wounds and other wounds, the skin bacteria infection caused by staphylococcus aureus. It has antibacterial and bacteriostatic effects.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean up the affected area with iodine.
    • Apply appropriate amount of this product to the bacteriostatic area.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
    • Avoid light, seal, keep in a cool, dry place.
    • The period of validity: 24 months.
  • Inactive ingredients

    vaseline
    borneol
    deionized water

  • Package Label - Principal Display Panel

    20 g NDC: 75251-001-01

    123

  • INGREDIENTS AND APPEARANCE
    RHUBARB BACTERIOSTATIC CREAM 
    jialunfuhe yellow jade paste paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75251-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG5 g  in 20 g
    LICORICE (UNII: 61ZBX54883) (LICORICE - UNII:61ZBX54883) LICORICE2 g  in 20 g
    RHUBARB (UNII: G280W4MW6E) (RHUBARB - UNII:G280W4MW6E) RHUBARB1 g  in 20 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    BORNEOL (UNII: M89NIB437X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75251-001-0120 g in 1 TUBE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    Labeler - Tonghua fuhe Pharmaceutical Co,Ltd (554530815)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tonghua fuhe Pharmaceutical Co,Ltd554530815manufacture(75251-001)
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