Your browser does not support JavaScript! GRX HICORT (HYDROCORTISONE ACETATE) SUPPOSITORY [GERITREX CORP]
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RxNorm Names

GRX HICORT (hydrocortisone acetate) suppository
[GERITREX CORP]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54162-015
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE0.025 g  in 2 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED COCO-GLYCERIDES 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-015-122 g in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/12/2013
Labeler - GERITREX CORP (112796248)
Registrant - GERITREX CORP (112796248)
Establishment
NameAddressID/FEIBusiness Operations
GERITREX CORP112796248manufacture(54162-015)

Revised: 11/2013
 
GERITREX CORP

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