Active Ingredient

Manufacturer
New World Imports, Inc.
Effective date
2026-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-16 05:10:18

Label at a glance#

ProductCAREALL Hydrocortisone Maximum Strength
Active ingredientHYDROCORTISONE
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

OTC - PURPOSE SECTION

Anti Itch

WARNINGS SECTION

For External use only.

Do not use for the treatment of diaper rash, Consult a doctor.

If you have vaginal discharge, consult a doctor.

When using this product:

avoid contact with eyes

do not use more than directed unless directed by a doctor

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

if rectal bleeding occurs, consult a docto promptly

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocrotisone product unless you have consulted a doctor.

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 physician.

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: ezcema, psoriasis, poison ivy, oak & sumac, insect bites, detergents, jewelry, seborrheic dermatitis, and soap

other uses of this product should be only under the advice and supervision of a doctor

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. Ask a doctor.

INACTIVE INGREDIENT SECTION

Ceteareth-20, Cetostearyl Alchohol, Chlorocresol, Edetate Disodium, Glycerol Monostearate, Mineral Oil, Propylene Glycol, Sodium Metabisulphate, Purified Water, White Petrolatum

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. if swallowed, get medical help or contat a poinson control center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51824-19751824-197-01, 51824-197-02, 51824-197-03, 51824-197-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.5114cdba-96a1-c399-e063-6294a90aac122026-05-06WarningsExact identifier
ndc (package): 51824-197-04
ndc (package): 51824-197-01
ndc (package): 51824-197-03
ndc (package): 51824-197-02
ndc (product): 51824-197
ndc11 (package): 51824019701
ndc11 (package): 51824019702
ndc11 (package): 51824019703
ndc11 (package): 51824019704
spl id: 51273eb3-752d-b118-e063-6394a90ad0bf
spl set id: 5114cdba-96a1-c399-e063-6294a90aac12

Reported adverse events (FAERS/openFDA)#

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