RxNorm Names

Review RxNorm Normal Forms

HYDRO SKIN (hydrocortisone) lotion
[Rugby Laboratories]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=bca3ff9b-bf2c-4a03-a1ff-bec084b0995b

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

for temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
eczema
psoriasis
poison ivy, oak, sumac
insect bites
detergents
jewelry
seborrheic dermatitis
soaps
external genital and anal itching
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. Ask a doctor.
for external genital itching if you have a vaginal discharge. Ask a doctor.

When using this product

avoid contact with the eyes
do not begin use of any other hydrocortisone product unless you have asked a doctor
for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
do not put this product 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. 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 right away.

Directions

shake well before use

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 itching:

adults: when practical, cleanse 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 application of this product.
children under 12 years of age with external anal itching: ask a doctor

Inactive ingredients

benzyll alcohol, emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, sorbitol 70% solution

Questions or comments?

1-800-645-2158

Package/Label Principal Display Panel

Rugby Laboratories

Maximum Strength

Anti-Itch Lotion

hydrocortisone 1%

HYDRO SKIN
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-5105
Route of Administration	TOPICAL	DEA Schedule

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

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

Packaging
#	Item Code	Package Description
1	NDC:0536-5105-97	118 mL in 1 BOTTLE

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: b92989a1-d34d-46cf-bb22-1ac92bd209b5

Set id: bca3ff9b-bf2c-4a03-a1ff-bec084b0995b

Version: 1

Effective Time: 20130115