KAISER PERMANENTE  HYDROCORTISONE- hydrocortisone ointment 
Kaiser Foundation Hospitals

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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KAISER PERMANENTE®
Hydrocortisone

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch ointment

Uses

Warnings

For external use only

Do not use

  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you have

  • a vaginal discharge
  • rectal bleeding
  • diaper rash

When using this product consult a doctor before exceeding recommended dosage

Stop use and ask a doctor if

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

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:

Children under 2 years of age: do not use. consult a doctor

For external anal itching

  • Adults: when practical, cleanse 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 application of this product

Children under 12 years of age: consult a doctor

Other information

Inactive ingredients

Fractionated Coconut Oil, Methylparaben, Propylparaben, White Petrolatum

Questions?

Call 1-866-923-4914

Manufactured by
Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1

Distributed by
Kaiser Foundation Hospitals
Livermore, CA 94551-9756

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

KAISER PERMANENTE®

Hydrocortisone 1% Ointment
ANTIPRURITIC (ANTI-ITCH) | MAXIMUM STRENGTH
RELIEVES ITCH AND RASH RELIEF

*Compare to the active ingredient in Cortizone•10®

NET WT 1 OZ (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
KAISER PERMANENTE   HYDROCORTISONE
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0179-8711
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Medium-chain triglycerides 
Methylparaben 
Propylparaben 
Petrolatum 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0179-8711-301 in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/03/1989
Labeler - Kaiser Foundation Hospitals (053052619)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(0179-8711)

Revised: 3/2013
Document Id: 4986e78a-ac51-461b-a8ea-d49bc4b26331
Set id: 5463e7e0-a809-4153-9ec7-93f9d16e6072
Version: 1
Effective Time: 20130321
 
Kaiser Foundation Hospitals