MAXIMUM-H- hydrocortisone cream 
New GPC, 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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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

PRINCIPAL DISPLAY PANEL - 20g Tube Carton
MAXIMUM-H 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65588-2210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PETROLATUM (UNII: 4T6H12BN9U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MINERAL OIL (UNII: T5L8T28FGP)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
LANOLIN (UNII: 7EV65EAW6H)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROLAMINE (UNII: 9O3K93S3TK)  
SOY ISOFLAVONES (UNII: 71B37NR06D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBIC ACID (UNII: X045WJ989B)  
MENTHOL (UNII: L7T10EIP3A)  
TRICAPRYLIN (UNII: 6P92858988)  
ESCULIN (UNII: 1Y1L18LQAF)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65588-2210-11 in 1 CARTON
120 g in 1 TUBE
2NDC:65588-2210-21 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/FEIBusiness Operations
New GPC, Inc.895025443MANUFACTURE

Revised: 10/2010
Document Id: 7b3a0d7b-acdb-4a98-a1e1-4319bfc754e6
Set id: eb9bf7f3-172b-40fb-93d3-cb4c633b3506
Version: 1
Effective Time: 20101013
 
New GPC, Inc.