FDA.reportPublic FDA data

Perrigo Anti- Itch Cream Drug Facts

Manufacturer
L. Perrigo Company
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:50:27

Label at a glance#

Productgood sense anti itch
Active ingredientHYDROCORTISONE
Label structure9 sections

Indications and uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: • eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • temporarily relieves external anal and genital itching • other uses of this product should only be 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: do not use, ask a doctor • for external anal and genital itching, adults: • when practical, clean the affected area with mild soap and warm water and rinse thoroughly • gently dry by patting or blotting with toilet tissu...

Storage and handling

• store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 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
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not use more than directed unless told to do so 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

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 right away. (1-800-222-1222)

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: do not use, ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, diazolidinyl urea, dimethicone, distearyldimonium chloride, edetate disodium, glycerin, glyceryl monostearate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, jojoba esters, magnesium ascorbyl phosphate, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, potassium hydroxide, PPG-12/SMDI copolymer, propylparaben, purified water, retinyl palmitate, stearamidopropyl PG-dimonium chloride phosphate, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helps Heal Itch Fast

Dry, Itchy Skin

Eczema & Psoriasis

Inflammation, Irritation & Redness

Calms, Nourishes, Hydrates

Safe for Sensitive Skin

#1 DOCTOR RECOMMENDED anti-itch active ingredient

With Antioxidants & Chamomile, Vitamins A, C & E

Clinically Proven to Moisturize 24 Hours

Maximum Strength

Anti-Itch Cream

Intensive Healing Formula

Hydrocortisone 1% Anti-Itch Creme

Compare to active ingredient of Cortizone - 10® Intensive Healing Formula

100% SATISFACTION GUARANTEED

NET WT 1 OZ (28g)

anti itch cream image
anti itch cream image

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1369GOOD SENSE ANTI ITCH (HYDROCORTISONE) CREAM [L. PERRIGO COMPANY]2Legacy NDC20241106_fe2be0f9-f563-4254-9a2c-b8d99f6b8ff1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-1369-64GM - Gram0113-1369ededc18d-e722-4000-9689-f32bf3f0363e12022-04-06

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0113-13690113-1369-64

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
ALOE VERA LEAFZY81Z83H0XIACT
OATZ6J799EAJKIACT
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CHAMOMILEFGL3685T2XIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DIMETHICONE92RU3N3Y1OIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
METHYL GLUCETH-20J3QD0LD11PIACT
METHYLPARABENA2I8C7HI9TIACT
PETROLATUM4T6H12BN9UIACT
POLYSORBATE 60CAL22UVI4MIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
STEARETH-2V56DFE46J5IACT
STEARETH-2153J3F32P58IACT
STEARYL ALCOHOL2KR89I4H1YIACT
STEARAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATEW6000VEI5YIACT
PPG-12/SMDI COPOLYMER1BK9DDD24EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
643c36bc-ab8e-4479-85dd-f178497cbf97fe2be0f9-f563-4254-9a2c-b8d99f6b8ff12024-11-05WarningsExact identifier
spl id: 643c36bc-ab8e-4479-85dd-f178497cbf97
spl set id: fe2be0f9-f563-4254-9a2c-b8d99f6b8ff1

Reported adverse events (FAERS/openFDA)#

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