Label: JIDESHENG- clotrimazole gel

  • 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 November 4, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                             Purpose
    Clotrimazole 1%                              Antifungal
  • INDICATIONS & USAGE

    Uses
    - cure most jock itch
    - relieve itching, burning, scaling, chafing and discomfort which accompany this condition.

  • WARNINGS

    Warnings - For external use only
    - do not use on children under 2 years of age unless directed by a doctor.
    - when use this product avoid contact with eyes
    - stop use and ask a doctor if irritation occurs or there is no improvement in 2 weeks
    - Keep out the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Direction
    - Wash the affected area and dry thoroughly
    - apply a thin layer over affected area twice daily (morning and night)
    - supervise children in the use of this product
    - use daily for 2 weeks
    - if condition persist longer, ask a doctor
    - this product is not effective on the scalp or nails
  • STORAGE AND HANDLING

    Storage: Store at 20-15 C (68-77 F)
  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, stearic acid, mineral, glyceryl monostearate, cetostearyl alcohol, menthol, sodium lauryl sulfate, ethyl paraben

  • ASK DOCTOR

    stop use and ask a doctor if irritation occurs or there is no improvement in 2 weeks
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • DO NOT USE

    do not use on children under 2 years of age unless directed by a doctor.
  • PURPOSE

    Antifungal

  • PRINCIPAL DISPLAY PANEL

                    JiDeSheng Anti-Itching Ointment
                                     ANTIFUNGAL
    Uses to relieve itching, burning, scaling, chafing and discomfort which accompany this condition.
                            For external use only
                            Product of China
                            Net wt. 1 oz. (30g)

    JiDeSheng Label


  • INGREDIENTS AND APPEARANCE
    JIDESHENG 
    clotrimazole gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51823-3574
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Mineral oil (UNII: T5L8T28FGP)  
    Stearic acid (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    Menthol (UNII: L7T10EIP3A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Ethylparaben (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51823-3574-71 in 1 BOX
    129 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/23/2010
    Labeler - UPC Medical Supplies, Inc. (942011719)
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