HYDROCORTISONE  - hydrocortisone acetate cream 
Dynarex Corporation

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Dynarex Hydrocortisone Cream 1%

Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

Uses:

For temporary relief of;

• minor skin irritations

Itching and rashes due to;

• eczema
• insect bites
• poison ivy
• poison oak
• poison sumac
• soaps
• detergents
• cosmetics
• jewelry

and for external itching of;

•  genital
• feminine and
• anal itching
  

Warnings:

For external use only

Do not use:

• in the eyes
• longer than 1 week unless directed by a physician
• for diaper rash
• if you have vaginal discharge
• more than the recommended daily dosage unless directed by a doctor
• in the rectum bu using fingers or any other mechanical device or applicator
  

Stop use and ask a physician if:

• the condition persists or gets worse
• symptoms clear up and occur again within a few days
• you are pregnant or breast feeding
  

Keep out of reach of children

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

Directions:

Adults and children over 2 years of age

• Apply evenly to affected area no more than 3 or 4 times daily.

Children under 2 years of age

• Do not use
• consult a physician

Adults

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
• apply externally to the area up to 6 times daily or after each bowel movement
  

Other information:

• Store at 20 deg - 25 deg C (68 deg - 77 deg F)
• Avoid excessive heat and humidity
  

Inactive ingredients:

Citric acid, Glycerin, Glycerol sterate, Methylparaben, Petrolatum, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium citrate, Titanium dioxide, Water (purified)

Principal Display Panel

Hydrocortisone Cream 1%

Indications and Usage

For temporary relief of minor skin irritations and external itching.

HYDROCORTISONE  hydrocortisone acetate   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 67777-224 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE   GLYCERIN   GLYCERYL MONOSTEARATE   METHYLPARABEN   PETROLATUM   POLYSORBATE 80   PROPYLENE GLYCOL   SODIUM CITRATE   TITANIUM DIOXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67777-224-01 72 TUBE In 1 CASE contains a TUBE 1 28.3 g In 1 TUBE This package is contained within the CASE (67777-224-01) 2 67777-224-08 12 JAR In 1 CASE contains a JAR 2 425 g In 1 JAR This package is contained within the CASE (67777-224-08)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	02/02/2010

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Operations
Choice Laboratories		650070394	manufacture

Revised: 03/2011Dynarex Corporation