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Drug Facts
Hydrocortisone
FDA Label NDC 49314-5801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unishield for the product Hydrocortisone (NDC 49314-5801). 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 other, warnings, do not use, stop use, as a doctor, keep out of reach of children., directions, inactive ingredients, active ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
For external use only
Do Not Use
- in eyes
- for treatment of diaper rash
Stop Use, As A Doctor
- if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
- with use of other hydrocortisone products
Keep Out Of Reach Of Children.
If ingested, contact a Poison Control Center right away
Directions
- apply to affected area not more than 3 to 4 times daily
- children under 2: ask a doctor
Inactive Ingredients
Emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax
Active Ingredient
Hydrocortisone 1.0%
Uses:
For temporary relief of itching associated with minor skin irritations, inflammation or rashes. Other uses of product should be only under the advice and supervision of a doctor.
Principle Display Panel
HYDROCORTISONE CREAM
1/32 oz. (0.9g)
Dist by:UniShield
San Fernando, CA 91340
ACTIVE INGREDIENT
Hydrocortisone 1.0%
USES: For temporary relief
of itching associated with
minor skin irritations, inflammation or rashes.
Other uses of product
should be only under
the advice and supervision
of a doctor.
Principle Display Panel (Hyd10 0000 01)
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