Hydrocortisone
FDA Label NDC 59779-318

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Hydrocortisone (NDC 59779-318). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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                            PurposeHydrocortisone 1%...................................External analgesic

Otc - Purpose

Active ingredient                            Purpose Hydrocortisone 1%...................................External analgesicUses Temporarily relieves itching associated with minor skin irritation and rashes due to saborrheic dermatitis and psoriasis. Other uses of this product should be only used under the advice and supervision of a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage




Directions 

- adults and children 2 years and older: apply to affected areas one to four times daily

- children under 2 years of age, do not use, consult a doctor

Warnings

Warnings For external use only. When using this product - do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.Stop use of this product and do not begin use of any other hydrocortisone product if- condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, unless you have consulted a doctor.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Flammable, Keep away from fire or flame.

Dosage & Administration

Directions- adults and children 2 years and older: apply to affected areas one to four times daily- children under 2 years of age, do not use, consult a doctor

Inactive Ingredient

Inactive Ingredients SD Alcohol 40-B, water, propylene glycol, menthol, tocopheryl acetate, aloe barbadensis leaf juice, meialeuce alternilolia (tea tree) leaf oil, disodium EDTA

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