Label: PIYANPING ANTIITCH- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL

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 January 30, 2012

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  • STORAGE AND HANDLING

    Storage: Store at 20-25 C (68-77 F)

  • INACTIVE INGREDIENT

    Inactive ingredients: camphor, menthol, stearic acid, ethylparaben, glyceryl monostearate, glycerin, mineral oil, and triethanolamine

  • ASK DOCTOR

    Stop use and ask a doctor if
    •    Condition worsens
    •    Symptoms persist for more than 7 days or clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

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

  • DO NOT USE

    Do not use
    •    For the treatment of diaper rash. Ask a doctor.
    •    For the external genital itching, if you have a vaginal discharge, ask a doctor.

  • PURPOSE

    ANTI-ITCH
  • WARNINGS AND PRECAUTIONS

    When using this product
    •    Avoid contact with eyes
    •    Do not begin use of any other hrdrocortisone product unless you have asked a doctor
    •    For external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
    •    Do not put this product into the rectum by using fingers or any mechanical device or applicator

  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose
    Hydrocortisone 1%...........................    Anti-itch

  • INDICATIONS & USAGE

    Uses
    temporarily relieve itching associated with minor skin irritations, inflammation, and rashes

  • WARNINGS

    Warnings - For external use only

  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 2 years of age and older:
    •    Apply to affected area no more than 3-4 times daily
    Children under 2 years of age:
    •    Do not use, ask a doctor

  • PRINCIPAL DISPLAY PANEL

     PIYANGING ANTI-ITCH LOTION
                            1% HYDROCORTISONE ANTI-ITCH LOTION
    Uses to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes
    For external use only
    Product of China
    Net wt. 0.67 oz. (20g)
    Image of Piyanpingantiitch label

  • INGREDIENTS AND APPEARANCE
    PIYANPING ANTIITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68085-8012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    camphor (synthetic) (UNII: 5TJD82A1ET)  
    menthol (UNII: L7T10EIP3A)  
    stearic acid (UNII: 4ELV7Z65AP)  
    ethylparaben (UNII: 14255EXE39)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    glycerin (UNII: PDC6A3C0OX)  
    mineral oil (UNII: T5L8T28FGP)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68085-8012-41 in 1 BOX
    120 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/16/2011
    Labeler - Guangdong Zhanjiang Jimin Pharmaceutical Company, Ltd. (654041649)
    Registrant - Guangdong Zhanjiang Jimin Pharmaceutical Company, Ltd (654041649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Zhanjiang Jimin Pharmaceutical Company, Ltd654041649manufacture
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