Label: TRUELIPIDS 1% HYDROCORTISONE BARRIER CREAM- hydrocortisone cream

  • 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 August 10, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient.........Purpose

    Hydrocortisone 1% .....Anti-itch

  • PURPOSE

    Uses

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if

    • condition worsens
    • rectal bleeding occurs
    • symptoms persist 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 asked a doctor
  • WARNINGS

    Warnings

    For external use only

    Do not use

    • in the genital area if you have a vaginal discharge. consult a doctor
    • for the treatment of diaper rash. consult a doctor

    when using this product

    avoid contact with eyes

    do not use more than directed unless told to do so by a doctor

    do not put directly into rectim by using fingers or any mechanical device or applicator

  • DOSAGE & ADMINISTRATION

    Directions

    • for itching of skin irritation, inflammation and rashes:
      • adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
      • children under 2 years of age: ask a doctor
      • for external anal and genital itching adult:
        • when practical clean the affected area with mild soap and water and rinse thoroughly
      • gently dry by patting or blotting with toilet tissueor a soft cloth before applying
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Caprylic/capric Triglyceride, Petrolatum, Neopentyl Glycol Diheptanoate, Glyceryl Stearate, Polyglyceryl-2 Stearate, Isostearyl Isostearate, Cetyl Allcohol, Propanediol (from Corn) , Glycerin, Stearyl Alcohol, Euphorbia Cerifera (Candelilla Wax), C10-30 Cholesterol/Lanosterol Esters, Potassium Stearate, Glycyrrhetinic Acid(from Licorice root), Glyceryl Distearate, Stearic Acid, Caprylyl Glycol, Xanthan Gum, Niacinamide, 1,2-Hexanediol, Phytospingosine, Disodium EDTA, Ceramide NP, Tocopherol

  • OTHER SAFETY INFORMATION

    Other information

    store at 20°-25ºC (68º-77ºF)

  • PRINCIPAL DISPLAY PANEL

    CLMD

    Sensitive Skin Care

    True Lipids

    1% Hydrocortisone Barrier Cream

    Net Wt 1.7 fl oz (50g)

    hydrocortisone

  • INGREDIENTS AND APPEARANCE
    TRUELIPIDS 1% HYDROCORTISONE BARRIER CREAM 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61387-252
    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
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    POTASSIUM STEARATE (UNII: 17V812XK50)  
    ENOXOLONE (UNII: P540XA09DR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CERAMIDE NP (UNII: 4370DF050B)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    WATER (UNII: 059QF0KO0R)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61387-252-0150 g in 1 TUBE; Type 0: Not a Combination Product08/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/10/2023
    Labeler - Claridei Laboratories (035627639)
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