1% HYDROCORTISONE (HYDROCORTISONE) CREAM [YUYAO JESSIE COMMODITY CO.,LTD.]

1% HYDROCORTISONE (HYDROCORTISONE) CREAM [YUYAO JESSIE COMMODITY CO.,LTD.]
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NDC 51414-107-01, 51414-107-02, 51414-107-03, 51414-107-04, 51414-107-05, 51414-107-06, 51414-107-07, 51414-107-08, 51414-107-09
Set ID 5f6acc2b-7a6e-7f98-e053-2991aa0a46e7
Category HUMAN OTC DRUG LABEL
Packager Yuyao Jessie Commodity Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredient

    Hydrocortisone 1%

    Purpose

    Anti-itch

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  • Use

    Temporarity relieves itching associated with minor skin irritations,inflammation and rashes due to :eczema,psoriasis ,insect bites,detergents,jewelry,cosmetics,soaps,seborrheic dermatitis and more

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  • WARNINGS

    For External use only.
    Do not use in or near the eyes,for diaper rash ;ask a doctor.

    ask a doctor before use if you are using any other hydrocortisone product.

    stop use and ask a doctor,if .conditon worsens or if symptoms persist ofr more than 7 days. symptoms last more than 7 days or clear up and occur again within a few days.

    keep out of reach of children

    if ingested,contact a Poison Control Center right away.

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  • Directions

    apply to affected area not more than 3 to times daily.

    Children under 2 years,do not use;ask a doctor.

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  • Inactive ingredients

    water,cetearyl alcohol,glycerin,ceteareth-20,isoproply myristate ,edta-2na,phenoxyethanol,tocopheryl acetate,aloe barbadensis leaf juice

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  • lebel
  • INGREDIENTS AND APPEARANCE
    1% HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51414-107
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETEARETH-2 (UNII: ATB309OMWW)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51414-107-01 0.9 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016
    2 NDC:51414-107-02 0.5 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016
    3 NDC:51414-107-03 10 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016
    4 NDC:51414-107-04 15 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016
    5 NDC:51414-107-06 20 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016
    6 NDC:51414-107-07 30 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016
    7 NDC:51414-107-08 60 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016
    8 NDC:51414-107-09 100 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016
    9 NDC:51414-107-05 50 g in 1 PACKAGE; Type 0: Not a Combination Product 12/01/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/01/2015
    Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
    Establishment
    Name Address ID/FEI Business Operations
    Yuyao Jessie Commodity Co.,Ltd. 529892305 manufacture(51414-107)
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