HYDROCORTISONE  MAXIMUM STRENGTH - hydrocortisone acetate cream 
New World Imports, Inc

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Drug Facts

Hydrocortisone Acetate 1%

Anti-Itch

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

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, external itching and anal itching.

Other uses of this product should be only under the advice and supervision of a doctor

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

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

Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin

HYDROCORTISONE   MAXIMUM STRENGTH hydrocortisone acetate   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 51824-515 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone Acetate (Hydrocortisone ) Hydrocortisone Acetate 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength Propylene Glycol   Petrolatum   Mineral Oil   Cetostearyl Alcohol   CETETH-20   Sodium Metabisulfite   Chlorocresol   Edetate Disodium   Water

Product Characteristics Color white (White Cream) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51824-515-01 28 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/30/2010

Labeler - New World Imports, Inc (075372276)

Revised: 08/2010New World Imports, Inc