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)

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	09/20/2010

Labeler - Insight Pharmaceuticals LLC (055665422)

Dermarest Eczema Medicated Lotion