Hydrocortisone with Aloe Maximum Strength

Manufacturer
H2-Pharma, LLC
Effective date
2023-02-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:36:54

Label at a glance#

ProductHydrocortisone with Aloe Maximum Strength
Active ingredientHYDROCORTISONE
Label structure11 sections

Indications and uses

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to eczema psoriasis insect bites poison ivy, oak, sumac detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should be only under the advice and supervision of a doctor

Dosage and administration

for itching of skin irritation, inflammation, and rashes 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: consult a doctor for external anal and genital itching adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before ...

Storage and handling

store at 15°-30°C (59°-86°F). Protect from freezing. before using any medication, read all label directions. Keep carton, it contains important information.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone USP, 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
    • eczema
    • psoriasis
    • insect bites
    • poison ivy, oak, sumac
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not use more than directed unless directed by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
  • do not begin the use of any other hydrocortisone product unless directed by a doctor
  • rectal bleeding occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for itching of skin irritation, inflammation, and rashes
    • 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: consult a doctor
  • for external anal and genital itching
    • adults: when practical, clean the affected area with mild soap and warm water; rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 15°-30°C (59°-86°F). Protect from freezing.
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera concentrate, cetyl alcohol, citric acid1, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate solution1, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax

1 Contains one or more of these ingredients to adjust pH

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

SPL UNCLASSIFIED SECTION

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61269-339-56
†Compare to the active ingredient in
Maximum Strength Cortaid®

Maximum Strength
Hydrocortisone Cream USP, 1% with Aloe

Anti-itch Cream

For external use only
For temporary relief of:
Psoriasis | Poison ivy | Insect bites | Inflammation and redness | Seborrheic dermatitis
Soothes itch, irritation, and rashes | Calming aloe vera itch relief

Net wt. 1 oz (28 g)

H2 pharma

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-339-56GM - Gram61269-339ec1c4612-553a-42d8-a1d4-ceb9a08f852c12021-07-15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61269-33961269-339-56

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c00b7309-7c65-484c-a861-0e8df093f6cd8f79eb58-4e3d-4fc5-a01a-1213b8b09a4c2023-02-07WarningsExact identifier
spl id: c00b7309-7c65-484c-a861-0e8df093f6cd
spl set id: 8f79eb58-4e3d-4fc5-a01a-1213b8b09a4c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.