SUNMARK  HYDROCORTISONE PLUS 12 MOISTURIZERS- hydrocortisone cream 
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.

----------

sunmark
Hydrocortisone Plus 12 Moisturizers

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

  • for external use only
  • avoid contact with the eyes

Stop using this product and ask a doctor

  • 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 this and all drugs 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 direction. Keep this carton. It contains important information.

Directions

For External Anal Itching Users

  • 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

aloe barbadensis, cetearyl alcohol, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

sunmark

hydrocortisone cream 1%

Antipruritic (Anti-Itch)
MAXIMUM STRENGTH PLUS 12 MOISTURIZERS

NET WT 1 OZ (28.4 g)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
SUNMARK   HYDROCORTISONE PLUS 12 MOISTURIZERS
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-441
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
cetostearyl alcohol (UNII: 2DMT128M1S)  
chamomile flower oil (UNII: 60F80Z61A9)  
citric acid monohydrate (UNII: 2968PHW8QP)  
corn oil (UNII: 8470G57WFM)  
glycerin (UNII: PDC6A3C0OX)  
glyceryl monostearate (UNII: 230OU9XXE4)  
isopropyl palmitate (UNII: 8CRQ2TH63M)  
maltodextrin (UNII: 7CVR7L4A2D)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
petrolatum (UNII: 4T6H12BN9U)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)  
sodium lauryl sulfate (UNII: 368GB5141J)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Vitamin A palmitate (UNII: 1D1K0N0VVC)  
cholecalciferol (UNII: 1C6V77QF41)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-441-72 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(49348-441)

Revised: 2/2013
Document Id: 1d0959e7-9d66-4ec2-aa39-6686aec42203
Set id: ed6b197d-972a-455d-86be-bf2e8ec12b16
Version: 1
Effective Time: 20130206
 
McKesson