Dermacort Cream
FDA Label NDC 54473-117

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Dermacort (NDC 54473-117). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient
Hydrocortisone 1%

Otc - Purpose

Purpose
Anti-itch

Indications & Usage

Uses

  • For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, psoriasis, , seborrheic dermatitis, poison ivy, poison oak, poison sumac, insect bites, soaps, detergents, and jewelery
  • Other use of this product should be only under the advice and supervision of a doctor.

Warnings

Warnings
For external use only.

Otc - When Using

When using this product avoid contact with the eyes.

Otc - Stop Use

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

Otc - Do Not Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Dosage & Administration

Directions 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.

Storage And Handling

Other information Do not store above 100°F.

Inactive Ingredient

Inactive ingredients Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Cetyl Alcohol, Cyclopentasiloxane, Deionized Water, Dimethicone, Glycerin USP, Glyceryl Stearate and PEG-100 Stearate, Isopropyl Palmitate, Melaleuca Oil, Methylparaben, Petrolatum USP, Propylparaben, Serareth-2, Steareth-21, Triethanolamine.

* Please review the disclaimer below.