TRUELIPIDS 1% HYDROCORTISONE BARRIER CREAM- hydrocortisone cream 
Claridei Laboratories

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.

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TrueLipids 1% Hydrocortisone Barrier Cream

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

Hydrocortisone 1% .....Anti-itch

Uses

Keep out of reach of children.

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

Stop use and ask a doctor if

Warnings

For external use only

Do not use

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

Directions

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 information

store at 20°-25ºC (68º-77ºF)

CLMD

Sensitive Skin Care

True Lipids

1% Hydrocortisone Barrier Cream

Net Wt 1.7 fl oz (50g)

hydrocortisone

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)

Revised: 8/2023
Document Id: 037395dc-5b97-052e-e063-6394a90a26e4
Set id: 037395dc-5b96-052e-e063-6394a90a26e4
Version: 1
Effective Time: 20230810
 
Claridei Laboratories