Hydrocortisone
FDA Label NDC 59779-322

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 59779-322). 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%.................................... Anti-itch cream

Otc - Purpose

Usestemporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:- eczema - insect bites - poison ivy, poison oak or poison sumac - soaps - detergents - cosmetics- jewlery - seborrheic dermatitis - psoriasis - other uses of this product: ask a doctor

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contacta Poison Control Center immediately.

Indications & Usage

Usestemporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: - eczema - insect bites - poison ivy, poison oak or poison sumac - soaps - detergents - cosmetics - jewlery - seborrheic dermatitis - psoriasis - other uses of this product: ask a doctorOther information- store at room temperature. Protect from freezing and excessive heat.- see carton or tube crimp for lot number and expiration date.

Warnings

Warnings For external use only. Do not use:- in the eyes - for the treatment of diaper rashAsk a doctor before use if you are using any other hydrocortisone productStop use and ask a doctor if- condition worsens, or if symptoms persist for more than 7 days - symptoms last more than 7 days or clear up and occur again within a few daysKeep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions  - adults and children 2 years and older:apply to affected area not more than 3 to 4 times daily- children under 2 years:do not use, ask a doctor

Inactive Ingredient

Inactive Ingredientsaloe barbadensis leaf juice, avena sativa kernal flour oat, beeswax, cetyl alcohol, citric acid,glyceryl stearate, isopropyl myristate, methylparaben, PEG-40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, sodium stearate, sorbic acid,stearyl alcohol, tocopheryl acetate

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