Label: 1% HYDROCORTISONE- hydrocortisone cream

  • NDC Code(s): 51414-107-01, 51414-107-02, 51414-107-03, 51414-107-04, view more
    51414-107-05, 51414-107-06, 51414-107-07, 51414-107-08, 51414-107-09
  • Packager: Yuyao Jessie Commodity Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 17, 2022

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  • Active Ingredient

    Hydrocortisone 1%

    Purpose

    Anti-itch

  • 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

  • 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.

  • Directions

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

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

  • Inactive ingredients

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

  • lebel

    1

  • INGREDIENTS AND APPEARANCE
    1% HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-107
    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
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51414-107-010.9 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2016
    2NDC:51414-107-020.5 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2016
    3NDC:51414-107-0310 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2016
    4NDC:51414-107-0415 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2016
    5NDC:51414-107-0620 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2016
    6NDC:51414-107-0730 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2016
    7NDC:51414-107-0860 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2016
    8NDC:51414-107-09100 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2016
    9NDC:51414-107-0550 g in 1 PACKAGE; Type 0: Not a Combination Product12/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2015
    Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Jessie Commodity Co.,Ltd.529892305manufacture(51414-107)
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