SUNMARK  HYDROCORTISONE- hydrocortisone ointment 
McKesson

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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sunmark
Hydrocortisone

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

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

other uses of this product should be only under the advice and supervision of a doctor.

Warnings

Stop using this product and ask a doctor

  • in case of bleeding
  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

  • if you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age

For External Anal Itching Users

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding, consult a doctor promptly
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • children under 12 years of age: consult a doctor

Keep out of the reach of children.

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

Before using any medication, read all label directions. Keep this carton. It contains important information.

Directions

Other information

Inactive ingredients

fractionated coconut oil, methylparaben, propylparaben, white petrolatum

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

sunmark

hydrocortisone ointment 1%

Antipruritic (Anti-Itch)

MAXIMUM STRENGTH

NET WT 1 OZ (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
SUNMARK   HYDROCORTISONE
hydrocortisone ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-522
Route of Administration TOPICAL DEA Schedule     
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
Medium-chain triglycerides (UNII: C9H2L21V7U)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-522-72 1 in 1 CARTON
1 28.4 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 10/03/1989
Labeler - McKesson (177667227)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49348-522)

Revised: 2/2013
Document Id: 7f8d90f1-5da5-4307-bce4-487cc80fe71d
Set id: 210079e9-3d2f-4489-b468-b96b145034ed
Version: 1
Effective Time: 20130207
 
McKesson