RxNorm Names

Review RxNorm Normal Forms

HYDROSKIN (hydrocortisone) cream
[Rugby Laboratories]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f1e4ee6a-d58a-4c23-b389-d477acb60911

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
eczema
psoriasis
poison ivy, oak, sumac
insect bites
detergents
jewelry
cosmetics
soaps
seborrheic dermatitis
temporarily relieves external anal and genital itching
other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

for the treatment of diaper rash. Ask a doctor.
in the genital area if you have a vaginal discharge. Ask a doctor.

When using this product

avoid contact with the eyes
for external anal itching, do not use more than directed. In case of bleeding, consult a doctor promptly
do not insert cream into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

Keep out of reach of children.

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

Directions

for itching of skin irritation, inflammation, and rashes:
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, ask a doctor
for external anal and genital itching, adults:
when practical, clean the affected area with mild soap and warm water and rinse thoroughly
gently dry by patting or blotting with toilet tissue or a soft cloth before applying
apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Other information

store at 15°-30°C (59°-86°F)
see box or crimp of tube for lot number and expiration date

Inactive ingredients

emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, sorbitol solution, Preservative: benzyl alcohol

Questions or comments?

1-800-645-2158

Principal Display Panel

Maximum Strength

Anti-Itch Cream

1% Hydrocortisone Anti-Itch Cream

HYDROSKIN
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-5108
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (HYDROCORTISONE)	HYDROCORTISONE	1 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL
GLYCERIN
WATER
ISOPROPYL PALMITATE
LACTIC ACID
SORBITOL

Product Characteristics
Color	WHITE (Off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:0536-5108-95	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/29/2012

Labeler - Rugby Laboratories (191427277)

Revised: 01/2013

Document Id: 3143369a-e265-4bf0-86c4-5e2b43f75b85

Set id: f1e4ee6a-d58a-4c23-b389-d477acb60911

Version: 1

Effective Time: 20130115

Rugby Laboratories

Daily Med

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