TRUELIPIDS ANTI-ITCH BARRIER (HYDROCORTISONE) CREAM [DERMDEAL, LLC DBA CHERYL LEE, MD SENSITIVE SKIN CARE]

TRUELIPIDS ANTI-ITCH BARRIER (HYDROCORTISONE) CREAM [DERMDEAL, LLC DBA CHERYL LEE, MD SENSITIVE SKIN CARE]
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NDC 61387-247-01, 61387-247-02
Set ID d2ce48d0-892f-4592-bd22-6f36303cb368
Category HUMAN OTC DRUG LABEL
Packager DermDeal, LLC dba Cheryl Lee, MD Sensitive Skin Care
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • Uses

    • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • psoriasis
    • poison iny, 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 advise and supervision of a doctor
  • 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 the rectum by using fingers or any mechanical devise or applicator

    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, and do not begin use of any other hydrocortisone product unless you have asked a doctor.
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 to 4 times daily.
    • children under 2 years of age: ask a doctor
    • ​for external anal and genital itching, adults:
    • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
  • Other Information

    • store at 20°C-25°C  (68°-77°F)
  • Inactive Ingredients

    Water, Caprylic/Capric Triglyceride(Coconut), Petrolatum, Neopentyl, Glycol Diheptanoate, Polyglyceryl-10 Pentastearate, Behenyl Alcohol, Sodium Searoyl Lactylate, Glyceryl Stearate, Isostearyl Isostearate, Glycerin, Cetyl Alcohol, 1,3 Propanediol (from Corn), C10-C30 Cholesterol/lanoserol Esters, Ceramide 3, Phytosphingosine, Candelilla Wax, Glycyrrhetinic Acid, Niacinamide, 1,2-Hexanediol, Caprylyl Glycol, Xanthan Gum, Disodium EDTA, may contain Gluconolactone.

  • PRINCIPAL DISPLAY PANEL

    Eczema Cream Carton

  • INGREDIENTS AND APPEARANCE
    TRUELIPIDS ANTI-ITCH BARRIER 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61387-247
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ENOXOLONE (UNII: P540XA09DR)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61387-247-021 in 1 CARTON03/01/2014
    1NDC:61387-247-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2014
    Labeler - DermDeal, LLC dba Cheryl Lee, MD Sensitive Skin Care (035627639)

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