Other
Drug Facts
Other information
- store at room temperature (donot freeze)
- tamper evident, do not use any opened or torn packets
Hydrocortisone Cream
FDA Label NDC 47682-211
13 label sections · Submitted to the FDA by Unifirst First Aid Corporation · 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 Hydrocortisone (NDC 47682-211). 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 - 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 - Active Ingredient
Active ingredient
Hydrocortisone 1.0%
Otc - Purpose
Purpose
Anti-itch
Indications & Usage
Uses
- for the temporary relief of itching associated with minor skin irritations, inflamation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
- 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
- with anyother Hydrocortisone product unless you have consulted adoctor
- if you have vaginal discharge, consulkt a doctor
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or lasts more than 7 days, or clears and occurs again within a few days
- you begin use of any other Hydrocortisone product unless you have consulted a doctor
- bleeding occurs
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
- for adults and children (2 years of age and older): apply to affected area 3 to 4 times daily
- children under 12 years of age: for external anal itching, consult a doctor
- children under 2 years of age: do not use, consult a doctor
- adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
- gently dry by patting or botting with toilet tissue or a soft cloth before application of this product
Inactive Ingredient
Inactive ingredients
emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax
Otc - Questions
Questions or Comments? 1-800-634-7680
Medi-First Hydrocortisone Label
MEDI-FIRST®
1% Hydrocortisone Cream
Temporary relief of itching associated with
minor skin irritation, inflammation and rashes
Product # 24369
10 units of 0.9gm (1/32oz) Packets
Package Label.Principal Display Panel
Medi First® Plus
Hydrocortisone Cream 1%
Temporary releif of itching associated with minor skin irritation, inflamation and rashes
25 units / Net Wt 0.9 g (1/32 oz)
Item #93373
* Please review the disclaimer below.
