Indications and uses
For the temporary relief of external itching. For temporary relief of itching associated with minor skin irritation and rashes.
Maximum-H
- Manufacturer
- New GPC, Inc.
- Effective date
- 2010-10-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:52:12
Label at a glance#
ProductMaximum-H
Active ingredientHYDROCORTISONE
Label structure8 sections
Dosage and administration
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.
Contacts and useful links#
Websitewww.maximum-h.com
www.maximum-H.com
www.maximum-H.comLabel contents#
Full prescribing information#
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
WARNINGS
For external use only.
OTC - WHEN USING SECTION
Avoid contact with eyes.
OTC - STOP USE SECTION
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.
OTC - DO NOT USE SECTION
Do not use for the treatment of diaper rash.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65588-2210-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d28c-8e05-e053-dbdaa90a074a | maximum-H |
| 65588-2210-2 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d28c-8e05-e053-dbdaa90a074a | maximum-H |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65588-2210 | MAXIMUM-H (HYDROCORTISONE) CREAM [NEW GPC, INC.] | 1 | Legacy NDC | 20101029_eb9bf7f3-172b-40fb-93d3-cb4c633b3506.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| C13-14 ISOPARAFFIN | INACTIVE INGREDIENT | E4F12ROE70 | 1 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| ESCULIN | INACTIVE INGREDIENT | 1Y1L18LQAF | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 1 | |
| LANOLIN ALCOHOLS | INACTIVE INGREDIENT | 884C3FA9HE | 1 | |
| LAURETH-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| METHYLPROPANEDIOL | INACTIVE INGREDIENT | N8F53B3R4R | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYOXYL 20 CETOSTEARYL ETHER | INACTIVE INGREDIENT | YRC528SWUY | 1 | |
| POLYOXYL 40 STEARATE | INACTIVE INGREDIENT | 13A4J4NH9I | 1 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | 1 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | 1 | |
| SOY ISOFLAVONES | INACTIVE INGREDIENT | 71B37NR06D | 1 | |
| TRICAPRYLIN | INACTIVE INGREDIENT | 6P92858988 | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Maximum-H
- HYDROCORTISONE
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65588-2210 | 65588-2210-1, 65588-2210-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POLYOXYL 40 STEARATE | POLYOXYL 40 STEARATE TYPE I | 13A4J4NH9I | SPONGE / TOPICAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LOTION / TOPICAL | 1.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SOFT TISSUE | 0.05 %w/v | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET / ORAL | 10 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAMUSCULAR | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAMUSCULAR | 10 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / RECTAL | 2 mg | ||
| POLYOXYL 40 STEARATE | POLYOXYL 40 STEARATE TYPE I | 13A4J4NH9I | SOLUTION / OPHTHALMIC | 7 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, EXTENDED RELEASE / ORAL | 0.03 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | POWDER, FOR SUSPENSION / ORAL | NA | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | CAPSULE / ORAL | 60 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / INTRAVENOUS | 0.05 %w/v | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION / ORAL | 5000 mg/5ml | ||
| POLYOXYL 20 CETOSTEARYL ETHER | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | CREAM / TOPICAL | 180 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION/ DROPS / ORAL | 4.15 mg/2.5ml | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| POLYOXYL 20 CETOSTEARYL ETHER | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | AEROSOL / TOPICAL | 5.5 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | EMULSION / TOPICAL | 0.25 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| POLYOXYL 40 STEARATE | POLYOXYL 40 STEARATE TYPE I | 13A4J4NH9I | AEROSOL, FOAM / TOPICAL | 2.83 %w/w | ||
| POLYOXYL 40 STEARATE | POLYOXYL 40 STEARATE TYPE I | 13A4J4NH9I | OINTMENT / OPHTHALMIC | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | LIQUID / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SYRUP / ORAL | 100 mg/1ml | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | TABLET / ORAL | 0.58 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION/ DROPS / OPHTHALMIC | 0.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | OINTMENT / TOPICAL | 1.2 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRACARDIAC | 2 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET, EXTENDED RELEASE / ORAL | 0.18 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CREAM / TOPICAL | 0.1 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| MENTHOL | MENTHOL | L7T10EIP3A | CONCENTRATE / ORAL | 0.05 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / TOPICAL | 126 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOAP / TOPICAL | 0.75 %w/w | ||
| MENTHOL | MENTHOL | L7T10EIP3A | MOUTHWASH / BUCCAL | 0.15 mg/1ml | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL / TRANSDERMAL | 6 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | CONCENTRATE / ORAL | 1 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | TABLET / ORAL | 60 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | POWDER / TOPICAL | 0.02 mg/mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7b3a0d7b-acdb-4a98-a1e1-4319bfc754e6 | eb9bf7f3-172b-40fb-93d3-cb4c633b3506 | 2010-10-13 | Warnings | 7b3a0d7b-acdb-4a98-a1e1-4319bfc754e6 eb9bf7f3-172b-40fb-93d3-cb4c633b3506 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.