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TrueLipids Anti-Itch Barrier

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100mL
Labeler: DermDeal, LLC dba Cheryl Lee, MD Sensitive Skin Care
NDC Code: 61387-247

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.

TRUELIPIDS ANTI-ITCH BARRIER 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61387-247
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL 
DOCOSANOL 
C10-30 CHOLESTEROL/LANOSTEROL ESTERS 
MEDIUM-CHAIN TRIGLYCERIDES 
CAPRYLYL GLYCOL 
CERAMIDE 3 
CETYL ALCOHOL 
EDETATE DISODIUM 
CANDELILLA WAX 
GLUCONOLACTONE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
ENOXOLONE 
ISOSTEARYL ISOSTEARATE 
NEOPENTYL GLYCOL DIHEPTANOATE 
NIACINAMIDE 
PETROLATUM 
PHYTOSPHINGOSINE 
POLYGLYCERYL-10 STEARATE 
PROPANEDIOL 
SODIUM STEAROYL LACTYLATE 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:61387-247-021 TUBE in 1 CARTON
1NDC:61387-247-0150 mL in 1 TUBE
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)

Revised: 12/2017
 
DermDeal, LLC dba Cheryl Lee, MD Sensitive Skin Care

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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