CORTISONE MAXIMUM STRENGTH - hydrocortisone cream 
CVS Pharmacy

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CVS Pharmacy, Inc. Maximum Strength 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

• for the treatment of diaper rash. Ask a doctor.
• in the genital area if you have a vaginal discharge. 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 barbadensis leaf juice, avena sativa (oat) kernel extract, benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, diazolidinyl urea, dimethicone, distearyldimonium chloride, edetate disodium, glycerin, glyceryl monostearate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, jojoba esters, magnesium ascorbyl phosphate, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, potassium hydroxide, PPG-12/SMDI copolymer, propylparaben, purified water, retinyl palmitate, stearamidopropyl PG-dimonium chloride phosphate, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate

Questions or comments?

1-800-719-9260

Principal Display Panel

Plus antioxidants & chamomile

Maximum Strength

Intense Healing

Clinically Proven to Moisturize

Relieves Itch Fast

Rash/Eczema/Psoriasis/Redness/Inflammation/Other skin irritations

Nourishes/Soothes/Moisturizes/Safe for sensitive skin

Contains healing moisturizers enriched with vitamins A, C & E

Compare to the active ingredient in Cortizone•10®

Maximum Strength

Cortisone

1% Hydrocortisone Anti-Itch Cream

Intense Healing

CORTISONE  MAXIMUM STRENGTH hydrocortisone   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 59779-369 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 ALOE VERA LEAF   OAT   BENZYL ALCOHOL   BUTYLATED HYDROXYTOLUENE   CETOSTEARYL ALCOHOL   CETYL ALCOHOL   CHAMOMILE   DIAZOLIDINYL UREA   DIMETHICONE   DISTEARYLDIMONIUM CHLORIDE   EDETATE DISODIUM   GLYCERIN   GLYCERYL MONOSTEARATE   HYDROLYZED JOJOBA ESTERS (ACID FORM)   MAGNESIUM ASCORBYL PHOSPHATE   MENTHYL LACTATE   METHYL GLUCETH-20   METHYLPARABEN   PETROLATUM   POLYSORBATE 60   POTASSIUM HYDROXIDE   PROPYLPARABEN   WATER   VITAMIN A PALMITATE   STEARETH-2   STEARETH-21   STEARYL ALCOHOL

Product Characteristics Color WHITE (Off white) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 59779-369-64 1 TUBE In 1 CARTON contains a TUBE 1 28 g In 1 TUBE This package is contained within the CARTON (59779-369-64) 2 59779-369-85 1 TUBE In 1 CARTON contains a TUBE 2 35 g In 1 TUBE This package is contained within the CARTON (59779-369-85)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/05/2010

Labeler - CVS Pharmacy (062312574)

Revised: 01/2010CVS Pharmacy