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NDC 63736-0339-24 Dermarest 10 mg/mL Details

Dermarest 10 mg/mL

Dermarest is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Insight Pharmaceuticals LLC. The primary component is HYDROCORTISONE.

MedlinePlus Drug Summary

Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Related Packages: 63736-0339-24
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	63736-0339
Product ID	63736-339_ca45ab8f-7078-4d91-be07-e3f7b244fcb8
Associated GPIs	90550075004115
GCN Sequence Number	007553
GCN Sequence Number Description	hydrocortisone LOTION 1 % TOPICAL
HIC3	Q5P
HIC3 Description	TOPICAL ANTI-INFLAMMATORY STEROIDAL
GCN	30974
HICL Sequence Number	002867
HICL Sequence Number Description	HYDROCORTISONE
Brand/Generic	Generic
Proprietary Name	Dermarest
Proprietary Name Suffix	Eczema Medicated
Non-Proprietary Name	Hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	HYDROCORTISONE
Labeler Name	Insight Pharmaceuticals LLC
Pharmaceutical Class	Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63736-0339-24 (63736033924)

Pricing Information	N/A
NDC Package Code	63736-339-24
Billing NDC	63736033924
Package	24 CARTON in 1 CASE (63736-339-24) / 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Marketing Start Date	2010-09-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0292ab62-5088-45fa-a056-70c2fcc19ef7 Details

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

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 NOT FINAL	part348	09/20/2010

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