Otc - Active Ingredient
Hydrocortisone acetate (equivalent to Hydrocortisone 1%)
Hydrocortisone Ointment
FDA Label NDC 51662-1284
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hf Acquisition Co Llc, Dba Healthfirst for the product Hydrocortisone (NDC 51662-1284). 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, dosage & administration, warnings, otc - do not use, otc - when using, otc - stop 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 - Purpose
Anti-itch cream
Dosage & Administration
for the temporary relief of itching associated with minor skin irritations and rashes
other uses of this product should be only under the advice and supervision of a doctor
Warnings
For external use only
Otc - Do Not Use
Do not use
for the treatment of diaper rash. Consult a doctor
Otc - When Using
When using this product
avoid contact with eyes
do not begin use of any other hydrocortisone product unless you've consulted a doctor
Otc - Stop Use
Stop use and ask a doctor if
condition worsens
symptoms persist more than 7 days
condition clears up and occurs again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
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; do not use, consult a doctor
Other Safety Information
clean the affected area
store at room temperature
do not use any opened or torn packets
you may report a serious adverse reaction to this product to 800-275-3433
Inactive Ingredient
cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water
How Supplied
2packs in 1pouch NDC (51662-1284-1)
Indications & Usage
Anti-itch ointment
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