Label: MEDI-CORTISONE WITH ALOE- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49614-404-10 - Packager: Medicine Shoppe International Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 24, 2012
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Uses
- temporary relief of itching associated with minor skin irritations and rashes due to
- eczema
- insect bites
- poison ivy, poison oak, or poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external genital and anal itching
- other uses of this product should be only under the advice and supervision of a doctor
- temporary relief of itching associated with minor skin irritations and rashes due to
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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
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
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INGREDIENTS AND APPEARANCE
MEDI-CORTISONE WITH ALOE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49614-404 Route of Administration TOPICAL 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)