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
- Purpose
-
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
- When using this product
- Keep out of reach of children.
-
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
-
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
-
INGREDIENTS AND APPEARANCE
TRUELIPIDS ANTI-ITCH BARRIER
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61387-247 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:61387-247-02 1 in 1 CARTON 03/01/2014 1 NDC:61387-247-01 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2014 Labeler - DermDeal, LLC dba Cheryl Lee, MD Sensitive Skin Care (035627639)