CORTISONE MAXIMUM STRENGTH - hydrocortisone cream 
CVS Pharmacy

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CVS Pharmacy, Inc. Cortisone Drug Facts

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

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

When using this product

• avoid contact with the eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly 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
• rectal bleeding occurs

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 20°-25°C (68°-77°F)

Inactive ingredients

aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Cortizone•10®

Maximum Strength

Cortisone

1% hydrocortisone Anti-Itch Cream

CORTISONE  MAXIMUM STRENGTH hydrocortisone   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 59779-319 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 No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 59779-319-16 1 TUBE In 1 CARTON contains a TUBE 1 56 g In 1 TUBE This package is contained within the CARTON (59779-319-16) 2 59779-319-64 1 TUBE In 1 CARTON contains a TUBE 2 28 g In 1 TUBE This package is contained within the CARTON (59779-319-64) 3 59779-319-58 1 TUBE In 1 CARTON contains a TUBE 3 14 g In 1 TUBE This package is contained within the CARTON (59779-319-58) 4 59779-319-26 2 TUBE In 1 CARTON contains a TUBE 4 56 g In 1 TUBE This package is contained within the CARTON (59779-319-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/02/2008

Labeler - CVS Pharmacy (062312574)

Revised: 07/2009CVS Pharmacy