HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment 
Stephen L. LaFrance Pharmacy, Inc.

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 1%

Purpose

Anti-itch

Uses

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

  • 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

  • in the eye
  • for external feminine itching if you have a vaginal discharge
  • for the treatment of diaper rash

When using this product

  • do not begin the use of any other hydrocortisone product
  • 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 come back in a few days
  • rectal bleeding occurs, consult promptly

Keep out of reach of children. 

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

Directions

For general use
•   adults and children 2 years and older: apply to affected area not more than 3 to 4 times a day
•   children under 2 years: do not use, ask a doctor

For external anal and genital itching
•   adults and children 12 years and older: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with a toilet tissue or a soft cloth before application.  Apply to affected area not more than 3 to 4 times a day
•   children under 12 years: ask a doctor

Inactive Ingredients

mineral oil, white petrolatum

Questions?

1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL

NDC 15127-128-01
MAXIMUM STRENGTH
select brand®
Hydrocortisone 1%
Anti-Itch Ointment
Relieves Itches and Helps Heal Rashes
Compare to the active ingredient of Cortizone•10®*
NET WT 1 OZ (28 g)

03450209B1             VC109046

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HYDROCORTISONE MAXIMUM STRENGTH 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-128
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:15127-128-011 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/13/2008
Labeler - Stephen L. LaFrance Pharmacy, Inc. (043562370)
Establishment
NameAddressID/FEIBusiness Operations
Actavis Mid Atlantic LLC809515898ANALYSIS(15127-128), MANUFACTURE(15127-128)

Revised: 05/2013
 
Stephen L. LaFrance Pharmacy, Inc.