DERMAREST ECZEMA MEDICATED- hydrocortisone lotion 
Insight Pharmaceuticals LLC

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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Dermarest Eczema Medicated Lotion

Dermarest™ Eczema
Medicated Lotion

Keep carton for future reference.

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporary relief of itching associated with

Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

For external use only

Do not use

for the treatment of diaper rash

When using this product

do not get into the eyes.

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children 2 years of age and olderapply to affected area not more than 3 to 4 times daily
children under 2 years of agedo not use, consult a doctor

Other Information

Inactive ingredients

Purified water, propylene glycol, glycerin, cetyl alcohol, glyceryl stearate, dimethicone, aleurites moluccana seed oil, zinc PCA, panthenol, carthamus tinctorius (safflower) flower extract, camellia sinensis leaf extract, rheum palmatum root/stalk extract, cyclohexasiloxane, cyclopentasiloxane, xanthan gum, disodium edetate, sodium hydroxide, diazolidinyl urea, methylparaben, propylparaben

Questions?

1-800-344-7239 www.Dermarest.com

PRINCIPAL DISPLAY PANEL 

Dermarest®

Eczema
Medicated

Lotion


Hydrocortisone 1%
Anti-Itch Lotion
4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL 
Dermarest®

Eczema
Medicated
Lotion

Hydrocortisone 1%
Anti-Itch Lotion
4 FL OZ (118 mL)

DERMAREST  ECZEMA MEDICATED
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-339
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
PANTHENOL (UNII: WV9CM0O67Z)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
RHEUM PALMATUM ROOT (UNII: G025DAL7CE)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-339-2424 in 1 CASE09/20/2010
11 in 1 CARTON
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34809/20/2010
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 1/2020
Document Id: ca45ab8f-7078-4d91-be07-e3f7b244fcb8
Set id: 0292ab62-5088-45fa-a056-70c2fcc19ef7
Version: 6
Effective Time: 20200110
 
Insight Pharmaceuticals LLC