TRUELIPIDS ANTI-ITCH BARRIER- hydrocortisone cream 
DermDeal, LLC dba Cheryl Lee, MD Sensitive Skin Care

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.

----------

TrueLipids Eczema Experts Anti-Itch 1% Hydrocortisone Barrier Cream

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.

Eczema Cream Carton

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 CARTON03/01/201411/30/2022
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 finalpart34803/01/201411/30/2022
Labeler - DermDeal, LLC dba Cheryl Lee, MD Sensitive Skin Care (035627639)

Revised: 6/2023
 
DermDeal, LLC dba Cheryl Lee, MD Sensitive Skin Care