HYDROCORTISONE CREAM USP 1% WITH ALOE

Manufacturer
Delsam Pharma Llc
Effective date
2018-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:49:36

Label at a glance#

ProductHYDROCORTISONE WITH ALOE
Active ingredientHYDROCORTISONE
Label structure11 sections

Indications and uses

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

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 external anal 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  Children under 12 years...

Storage and handling

• Store at room temperature 59°-89°F (15°-30°C). Protect from freezing. • Before using any medication, read all label directions. Keep carton, it contains important information.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone, USP 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema • insects bites • poison ivy • poison oak • poison sumac • soaps • jewelry • detergents • cosmetics • psoriasis • seborrheic dermatitis

• for external genital, feminine and anal 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 • for external feminine itching if you have a vaginal discharge. Consult a doctor.

• for the treatment of diaper rash. Consult a doctor.

When using this product • avoid contact with the eyes • do not begin the use of any other hydrocortisone product unless directed by a doctor • for external anal itching:

• do not use more than directed by a doctor

• do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if • symptoms last for more than 7 days • the condition gets worse • symptoms clear up and occur again in a few days

• rectal bleeding occurs, consult doctor promptly

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 external anal 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 

Children under 12 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera concentrate, Cetomacrogol 1000, Cetostearyl alcohol, White Petroleum Jelly, Propylene glycol, Light Liquid Paraffin, Monobasic Sodium Phosphate, Propyl Paraben, Methyl Paraben, Chlorocresol, Purified Water

Other information

STORAGE AND HANDLING SECTION

• Store at room temperature 59°-89°F (15°-30°C). Protect from freezing.

• Before using any medication, read all label directions. Keep carton, it contains important information.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-826-1306 between 9am and 4 pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

For Temporary relief of

* Skin irritations, Inflammation, & Rashes

* Insect Bites, Eczema & Psoriasis

Compare to the active ingredient in Cortaid Maximum Strength Cream *

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Cortaid®

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72570-106-302023-03-16C16284748780-19d75b9d0-e755-f424-e053-dadaa90a57ceHYDROCORTISONE CREAM USP 1% WITH ALOE
72570-106-302020-01-31C16284748780-19d75b9d0-e755-f424-e053-dadaa90a57ceHYDROCORTISONE CREAM USP 1% WITH ALOE

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72570-10672570-106-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
f3993e03-b5be-442c-a50c-35731b8ec72ce74fdb95-0c12-405e-af7b-a7a691feddec2023-03-15WarningsExact identifier
spl set id: e74fdb95-0c12-405e-af7b-a7a691feddec

Reported adverse events (FAERS/openFDA)#

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