ProCure Hydrocortisone Cream + Calendula

Manufacturer
Profoot, Inc. | Concept Laboratories, Inc.
Effective date
2017-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:19:32

Label at a glance#

ProductProCure Hydrocortisone Plus Calendula
Active ingredientHYDROCORTISONE
Label structure13 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: 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 befo...

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Active ingredients (each gram contains)

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

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

OTC - WHEN USING SECTION

When using this product

  • avoid contact with 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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • rectal bleeding occurs
  • 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

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

  • 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: 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 room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Butylene Glycol, Calendula Officinalis Flower Extract, Caprylyl Glycol, Ceratonia Siliqua (Carob) Gum, Ceteareth-20, Cetearyl Alcohol, Chondrus Crispus (Carrageenan), Cocos Nucifera (Coconut) Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Isopropyl Myristate, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-526-3668

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength

HYDROCORTISONE + CALENDULA

NO Parabens

NO Petrolatum

NO Alcohol

ORGANIC Calendula

ORGANIC Coconut Oil

ORGANIC Olive Oil

1% HYDROCORTISONE ANTI-ITCH CREAM

Net wt 1oz (28 g)

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29784-17129784-171-41, 29784-171-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
d2bd8825-c167-e7ff-e053-2a95a90a3c1c4881c9b1-b9cf-1b48-e054-00144ff88e882022-03-23WarningsExact identifier
spl set id: 4881c9b1-b9cf-1b48-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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