HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream 
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Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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:
  • do not use more than directed unless directed by a doctor
  • 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 59º-86ºF (15º-30ºC). Protect from freezing.
  • Before using any medication, read all label directions. Keep carton, it contains important information.

INACTIVE INGREDIENTS

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.

OTC - QUESTIONS

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Cortaid® Maximum Strength Cream

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Maximum Strength

HYDROCORTISONE CREAM, USP 1%

ANTI-ITCH CREAM

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

Relieves Itches and Rashes

NET WT 1 OZ (28g)

03430311B1 VC110485

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CARTON LABEL

HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
POLYOXYL 40 STEARATE 
POLYSORBATE 60 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
WHITE WAX 
METHYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:68016-102-011 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/08/2006
Labeler - Premier Value (101668460)

Revised: 04/2012
 
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