QUADRYDERN (HYDROCORTISONE) CREAM [PRODUCTOS ZAPOTOL CORP]

QUADRYDERN (HYDROCORTISONE) CREAM [PRODUCTOS ZAPOTOL CORP]
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NDC 59428-000-56
Set ID ac33aa42-4606-4b7f-8c21-477fbb7ac92f
Category HUMAN OTC DRUG LABEL
Packager Productos Zapotol Corp
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient                                                                        Purpose

    Hydrocortisone 1%..................................................Antipruritic (Anti-itch)

  • PURPOSE

    Uses

    • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
    • for external genital, feminine and anal itching
    • other uses of this product should be only under the advice and supervision of a doctor
  • WARNINGS

    Warnings For external use only

  • DO NOT USE

    Do not use for the treatment of diaper rash, consult a doctor.

  • ASK DOCTOR

    Ask a doctor before use if you have a vaginal discharge (for external feminine itching)

  • WHEN USING

    When using this product

    • avoid contact with the eyes
    • 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 rectum by using finger or any mechanical device or applicator.
  • STOP USE

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of the Reach Of Children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • Adults and Children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: do not use, consult a doctor.
    • Adults: for external anal itching:
    • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with and appropriate cleansing pad
    • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
    • children under 12 years of age: for external anal itching, consult a doctor
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients aloe vera leaf, butylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Productos Zapotol Corp.

    Van Nuys, CA 91402

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    140

  • INGREDIENTS AND APPEARANCE
    QUADRYDERN 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59428-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59428-000-561 in 1 CARTON06/30/2013
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2013
    Labeler - Productos Zapotol Corp (186063850)

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