DERMAREST ECZEMA MEDICATED- hydrocortisone lotion

Dermarest by

Drug Labeling and Warnings

Dermarest by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• minor skin irritations
  
• inflammation
  
• rashes due to eczema

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 older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, consult a doctor

Other Information

• shake well
  
• store at room temperature 15° - 25°C (59°- 77°F)

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)

INGREDIENTS AND APPEARANCE

DERMAREST  ECZEMA MEDICATED
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-339
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-339-24	24 in 1 CASE	09/20/2010
1		1 in 1 CARTON
1		118 mL in 1 BOTTLE; 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	09/20/2010

Labeler - Insight Pharmaceuticals LLC (055665422)