Hydrocortisone Anti-Itch Cream

Manufacturer
Gentell LLC
Effective date
2026-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-25 01:03:33

Label at a glance#

ProductClaravie
Active ingredientHYDROCORTISONE ACETATE
Label structure15 sections

Indications and uses

For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and 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

For itching of skin irritation, inflammation and rashes: - Adults and children over 2 years of age: - apply evenly 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 and genital itching, adults: - when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly - gently dry, patting or blotting with bathroo...

Storage and handling

Store at 66°F–77°F (20°C–25°C) Avoid excessive heat and humidity

Label contents#

Full prescribing information#

DESCRIPTION SECTION


Powered by nature, perfected by science—the ClaraVie™ skin care collection offers a harmonious blend of advanced technology and natural ingredients for radiant, healthy skin.

Active Ingredient (per gram)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone Acetate USP (1% w/w)

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and 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

OTC - DO NOT USE SECTION

  • in the eyes
  • for the treatment of diaper rash
  • if you have vaginal discharge
  • more than the recommended dosage

When using this product

OTC - WHEN USING SECTION

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

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you are pregnant or breastfeeding

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

INSTRUCTIONS FOR USE SECTION

  • For itching of skin irritation, inflammation and rashes:

- Adults and children over 2 years of age:

- apply evenly 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 and genital itching, adults:

- when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- gently dry, patting or blotting with bathroom tissue or soft cloth before applying
- apply externally to the area up to 6 times daily or after each bowel movement

- after application, discard pad

- do not flush in toilet

DOSAGE & ADMINISTRATION SECTION

For external anal and genital itching, adults:

when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
gently dry, patting or blotting with bathroom tissue or soft cloth before applying
apply externally to the area up to 6 times daily or after each bowel movement

Other Information

STORAGE AND HANDLING SECTION

  • Store at 66°F–77°F (20°C–25°C)
  • Avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetomacrogol 1000, Cetearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin.

Hydrocortisone Anti-Itch Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocortisone Anti-Itch Cream Label:

Hydrocortisone creamHydrocortisone cream

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-31161554-311-11, 61554-311-21, 61554-311-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
ClaravieHYDROCORTISONE ACETATEGentell LLC598d224b-d12e-89bf-e063-6394a90a84dc2026-08-21WarningsExact identifier
ndc (package): 61554-311-21
ndc (package): 61554-311-31
ndc (package): 61554-311-11
ndc (product): 61554-311
ndc11 (package): 61554031121
ndc11 (package): 61554031131
ndc11 (package): 61554031111
spl id: 598d224b-d12f-89bf-e063-6394a90a84dc
spl set id: 598d224b-d12e-89bf-e063-6394a90a84dc

Reported adverse events (FAERS/openFDA)#

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