MEDI-CORTISONE  WITH ALOE- hydrocortisone cream 
Medicine Shoppe International 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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Medi-Cortisone™ Cream 1%
Hydrocortisone Cream 1% with Aloe

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch cream

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

aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, stearyl alcohol

Distributed by:
MEDICINE SHOPPE
INTERNATIONAL., INC.

Earth City, MO 63045

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

NDC 49614-404-10

100%
GUARANTEED ®
SATISFACTION

Maximum Strength
Medi-Cortisone™
Cream 1%
Hydrocortisone Cream 1%
Antipruritic (Anti-Itch)

NET WT 1 oz
(28.4 g)

Principal Display Panel - 28.4 g Tube Carton

MEDI-CORTISONE   WITH ALOE
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49614-404
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
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
glyceryl monostearate (UNII: 230OU9XXE4)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49614-404-10 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 08/23/1995
Labeler - Medicine Shoppe International Inc (071997654)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (173762329)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49614-404)

Revised: 9/2012
Document Id: aab81888-3f53-4f5d-814f-193835e923f4
Set id: 4214482b-b6c3-4ec1-aa15-c8561f37f55d
Version: 2
Effective Time: 20120924
 
Medicine Shoppe International Inc