HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream

Hydrocortisone Maximum Strength by

Drug Labeling and Warnings

Hydrocortisone Maximum Strength by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Teva Pharmaceuticals USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema
• insect bites
• poison ivy
• poison oak
• poison sumac
• soaps
• jewelry
• detergents
• cosmetics
• psoriasis
• seborrheic dermatitis
• for external genital, feminine and anal itching
• other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• for external feminine itching if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.

When using this product

• avoid contact with the eyes

• do not begin the use of any other hydrocortisone product unless directed by a doctor

• for external anal itching:
                  o   do not use more than directed unless directed by a doctor   
                  o   do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• symptoms last for more than 7 days
• the condition gets worse
• symptoms clear up and occur again in a few days
• rectal bleeding occurs, consult doctor promptly

Keep out of reach of children. 

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

Directions

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, consult a doctor

For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, 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: consult a doctor

Other Information

• Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
• Before using any medication, read all label directions.  Keep carton, it contains important information.
  

Inactive Ingredients

aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL

Well at Walgreens

MAXIMUM STRENGTH
Hydrocortisone Cream, USP 1% with Aloe
Anti-Itch Cream

For the temporary relief of itches & rashes due to:
 

Insect bites
 Eczema
Poison ivy, oak, sumac
Seborrheic dermatitis
External genital, feminine & anal itching
Psoriasis
Detergents, jewelry & cosmetics

Compare to Cortizone10® Active Ingredient‡‡
Relieves itches & rashes
NET WT 1 OZ (28 g)

03390311B1             VC110440

Carton Image 1

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INGREDIENTS AND APPEARANCE

HYDROCORTISONE MAXIMUM STRENGTH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0339
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBIC ACID (UNII: X045WJ989B)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WHITE WAX (UNII: 7G1J5DA97F)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
May contain	SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0339-56	1 in 1 CARTON	07/16/2010	01/31/2017
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0363-0339-57	1 in 1 CARTON	07/16/2010
2		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	07/16/2010

Labeler - Walgreen Company (008965063)

Registrant - Teva Pharmaceuticals USA, Inc. (001627975)