HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment 
Actavis Mid Atlantic LLC

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 due to 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 eyes
  • 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:
  • 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 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 itch

  • 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 of this product
  • children under 12 years: ask a doctor

INACTIVE INGREDIENTS

Mineral oil, white petrolatum.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0472-0345-56

Anti-Itch Ointment

Hydrocortisone OINTMENT USP 1%

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

Actavis

MAXIMUM STRENGTH

Maximum Strength Formula for Temporary Relief of Itching Associated with Irritations, Inflammation and Rashes Due to:

  • Poison Ivy, Oak, Sumac
  • Eczema
  • Insect Bites
  • Seborrheic Dermatitis
  • External Genital or Anal itch

NET WT 1 OZ (28 g)

03450203C1 VC106543

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CARTON LABEL

HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-0345
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:0472-0345-561 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/1998
Labeler - Actavis Mid Atlantic LLC (809515898)

Revised: 04/2012
 
Actavis Mid Atlantic LLC