GRX HICORT- hydrocortisone acetate suppository 
GERITREX CORP

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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GRx HiCort 25

Drug Facts

Each suppository contains Hydrocortisone Acetate 25mg

Usage

In inflamed hemrrhoids, post irradiation (factitial) proctitis as an adjunct in the treatement of chronic ulcerative colitis, cryptitis and other

inflammatory condition of anorectum and pruritus ani

Directions

Detach one suppository from the strip of suppositories

Remove wrapper before inserting into the rectum as follows hold suppository upright and carefully separate foil by inserting the tips of fingernail

at the foil split

Peel slowly and evenly down both sides, exposing suppository

Avoid excessive handling of suppository which is designed to melt at body temperatures

Insert one suppository rectally as directed in dosage and administration

Hydrogenated cocoglyceride

Dosage and Administraion

One suppository in the rectum morning and night for two week, in nonspecific proctitis In more severe cases, one suppository three time daily

or two suppository twice daily in factitial proctitis, recommended therapy is six to eight weeks or less, according to response. For full prescribing information, see package insert

Avoid contact with eyes

Store at room temperature 59'-86'F (15'-30'C)

Avoid freezing

Keep away from children

Label of Box

GRX HICORT 
hydrocortisone acetate suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-015
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 0.025 g  in 2 g
Inactive Ingredients
Ingredient Name Strength
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54162-015-12 2 g in 1 BOX, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/12/2013
Labeler - GERITREX CORP (112796248)
Registrant - GERITREX CORP (112796248)
Establishment
Name Address ID/FEI Business Operations
GERITREX CORP 112796248 manufacture(54162-015)

Revised: 11/2013
Document Id: 44f1708c-4157-4c4d-9c04-26d419be7083
Set id: 980d2eef-9a1e-4476-9fcf-52b7187b5313
Version: 1
Effective Time: 20131112
 
GERITREX CORP