Medication Guide App

Maximum-H

Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: New GPC, Inc.
NDC Code: 65588-2210

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.

maximum-H

Active Ingredient

Hydorcortisone 1%

Purpose

Anti-itch ointment

Uses

For the temporary relief of external itching.

For temporary relief of itching associated with minor skin irritation and rashes.

Inactive ingredients

Water, Petrolatum, Hydrogenated Didecene Cetearyl Alcohol, Ceteareth-20, Lanolin, Mineral Oil, Glycerin, Sorbitan Stearate, Dimethicone, Methylpropanediol, PEG-40 Stearate, Lanolin Alcohol, Esculin, Disodium EDTA, Magnesium Aluminum Silicate, Acrylates/10-30 Alkyl Acrylate, Grosspolymer, 1,2-Hexanediol, Caprylyl Glycol, BHT, Soy, Isoflavones, Sodium Hydroxide, Phenoxyethanol, Sorbic Acid, Menthol, Tricaprylin, Polymethyl Methacrylate, Polyacrylamide, C13-14 Isoparafin, Laureth-7, Citric Acid.

Questions or Comments?

MossPharmacutical, P.O. Box 1426, Port Washington, NY 11050

www.maximum-H.com

WARNINGS

For external use only.

Avoid contact with eyes.

If condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you consult a doctor.

Do not use for the treatment of diaper rash.

Keep out of the reach of children. If swallowed get help or contact a Poison control center right away.

Directions

Adults and Children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Do not use, consult a Doctor.

For hemorrhoids - clean affected area with a cleansing wipe, then dry with a soft cloth. Apply externally to lower part of anal canal only. Apply up to 3 times daily at night and after every bowel movement.

PRINCIPAL DISPLAY PANEL - 20g Tube Carton

For Rapid and Effective relief of symptoms of Hemmorhoids.

maximum-H

Hemmorhoid-Symptom relief from Burning Itching and Swelling.

20g

MAXIMUM-H 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65588-2210
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
EDETATE DISODIUM 
MAGNESIUM ALUMINUM SILICATE 
METHYLPROPANEDIOL 
GLYCERIN 
CETOSTEARYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
PETROLATUM 
CAPRYLYL GLYCOL 
BUTYLATED HYDROXYTOLUENE 
MINERAL OIL 
LANOLIN ALCOHOLS 
LANOLIN 
SORBITAN MONOSTEARATE 
POLYOXYL 40 STEARATE 
DIMETHICONE 
TROLAMINE 
SOY ISOFLAVONES 
PHENOXYETHANOL 
SORBIC ACID 
MENTHOL 
TRICAPRYLIN 
ESCULIN 
C13-14 ISOPARAFFIN 
LAURETH-7 
Packaging
#Item CodePackage Description
1NDC:65588-2210-11 TUBE (TUBE) in 1 CARTON
120 g in 1 TUBE
2NDC:65588-2210-21 TUBE (TUBE) in 1 CARTON
240 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/01/2009
Labeler - New GPC, Inc. (895025443)
Establishment
NameAddressID/FEIOperations
New GPC, Inc.895025443MANUFACTURE

Revised: 10/2010
 
New GPC, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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