Label: MAXIMUM-H- hydrocortisone cream

  • 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 October 13, 2010

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  • 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
  • INGREDIENTS AND APPEARANCE
    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
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