Label: UNISHIELD 1%- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient

    Hydrocortisone 1%

  • PURPOSE

    Purpose  Anti-itch

  • INDICATIONS & USAGE

    Uses

    • for temorary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, posison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
    • 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

    • for the treatment of diaper rash
    • in eyes
    • for feminine itching

    When using this product:

    • Keep out of eyes, ears, and mouth
    • In case of contact with eyes, rinse eyes throughly with water

    Stop use and ask a doctor if 

    condition worsens or lasts more than 7 days, or clears and occurs again within a few days

    you begin use of other hydrocortisone product unless you have consulted a doctor

    bleeding occurs

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions 

    • For adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
    • children under 12 years of age: for external anal itching, consult a doctor
    • 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 an appropriate cleansing pad
    • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature (do not freeze)
    • Tamper evident, do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolactum, phenoxyethanol, water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    UNISHIELD 1% 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-0005
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-0005-125 in 1 BOX11/15/2023
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/15/2023
    Labeler - Unishield (790677053)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(49314-0005)