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Drug Facts
Medi-first 1% Hydrocortisone Cream
FDA Label NDC 47682-923
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Medi-first 1% Hydrocortisone (NDC 47682-923). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, 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 acetate (equivalent to Hydrocorisone 1%)
Otc - Purpose
Purpose
Anti-itch cream
Indications & Usage
Uses
- 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
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 for more than 7 days
- condition clears up and occurs again within a few days
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.
Dosage & Administration
Directions
- adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
- children under 2 years of age: do not use, consult a doctor
Other Safety Information
Other information
- clean the affected area
- store at room temperature (do not freeze)
- tamper evident. Do not use any opened or torn packets
- you may reportr a serioud adverse reaction to this product to 800-634-7680
Inactive Ingredient
Inactive ingredients
cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water
Otc - Questions
Questions or comments? 1-800-634-7680
Package Label.Principal Display Panel
Medi-First®
1% Hydrocortisone Cream
Temporary relief of itching associated with minor skin irritation and rashes
Item #21173
0.9 g (1/32 oz)
Packets - 25 per box
Medi-First® Plus
Hydrocortisone Cream 1%
Temporary relief of itching associated with minor skin irritations and rashes
25 Units/Net Wt 0.9 g (1/32 oz)
* Please review the disclaimer below.
