Pediaderm HC

Name: Pediaderm HC

Pediaderm HC Overview

Pediaderm HC is a brand name medication included in the following groups of medications: Corticosteroids acting locally, Corticosteroids for local oral treatment, Antiinflammatory Corticosteroids, Corticosteroids, weak group I, Corticosteroids, weak, other combinations, Corticosteroids/antiinfectives/mydriatics in combination, Glucocorticoids. For more information about Pediaderm HC see its generic Hydrocortisone

Manufacturer

  • Arbor Pharmaceuticals, Inc.

What is the most important information I should know about Pediaderm HC (hydrocortisone topical)?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I discuss with my healthcare provider before using Pediaderm HC (hydrocortisone topical)?

You should not use this medicine if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

  • diabetes;

  • liver disease; or

  • problems with your adrenal gland.

It is not known whether hydrocortisone topical will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether hydrocortisone topical passes into breast milk or if it could affect a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.

Do not use this medicine on a child without medical advice.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

An overdose of hydrocortisone topical is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Pediaderm HC (hydrocortisone topical)?

Do not take by mouth. Hydrocortisone topical is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medication gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Rinse with water if this medication gets in your eyes.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

How is Pediaderm HC Supplied

PEDIADERM-HC (Hydrocortisone Lotion USP 2%) is supplied in 1 fluid ounce (29.6 mL) dispenser bottles (NDC: 24338-316-30) and 3 mL packets (NDC: 24338-316-03).

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

Manufactured for:
Arbor Pharmaceuticals, Inc.
Atlanta, GA 30328

Rev. 08/12
P1402.03

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 24338-420-01

pediaderm®HC
Hydrocortisone Lotion USP 2%

COMPLETE KIT

Pediaderm® HC
Complete Kit includes:

pediaderm®HC
Hydrocortisone Lotion USP 2%

pediaderm®
Protective Emollient

ONE UNIT
DO NOT DISPENSE SEPARATELY

For Topical Use Only
Rx ONLY

arbor®
PHARMACEUTICALS, INC.

Established Pharmacological Class
Substance Pharmacological Class
Pediaderm Protective Emollient Lotions, Oils, Powders, and Creams
Pediaderm HC 
hydrocortisone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24338-420
Packaging
# Item Code Package Description
1 NDC:24338-420-01 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 29.6 mL
Part 2 1 TUBE 85 g
Part 1 of 2
Pediaderm HC 
hydrocortisone lotion
Product Information
Item Code (Source) NDC:24338-316
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone (Hydrocortisone) Hydrocortisone 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
isopropyl alcohol  
polysorbate 20  
propylene glycol  
benzalkonium chloride  
Packaging
# Item Code Package Description
1 NDC:24338-316-30 29.6 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083231 11/02/2009
Part 2 of 2
PEDIADERM   PROTECTIVE EMOLLIENT
inert cream
Product Information
Route of Administration TOPICAL DEA Schedule     
Ingredients
Ingredient Name Quantity
Water  
petrolatum  
glycerin  
mineral oil  
cetyl alcohol  
stearyl alcohol  
polyoxyl 20 cetostearyl ether  
ceramide 3  
isononyl isononanoate  
ethylhexyl isononanoate  
sodium laurate  
methylparaben  
propylparaben  
polyaminopropyl biguanide  
citric acid monohydrate  
cow milk fat  
Packaging
# Item Code Package Description
1 85 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 11/02/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083231 11/02/2009
Labeler - Arbor Pharmaceuticals, Inc. (781796417)
Revised: 10/2013   Arbor Pharmaceuticals, Inc.
(web3)