Medi-first Cream
FDA Label NDC 71927-032
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Orazen Inc for the product Medi-first (NDC 71927-032). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, 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
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-itch
Uses
- for the temporary relief of itching associated with minor skin irritation,inflammation and rashed due to eczema, insect bites, poison ivy, poison oak,poison sumac, soaps, detergents, cosmetics,jewelry, sebortheic dermatitis, psoriasis and scrapes
- other uses of this product should be only under the advice and supervision of a doctor
Warnings
For external use only
Do Not Use
- for treatment of diaper rash
- in eyes
- for feminine itching
Stop Use And Ask A Doctor If
- condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
- you begin use of any other hydrocortisone product
- bleeding occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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 blotting with toilet tissue or a soft cloth before application of this product
(continued on side panel)
Other Information
- store at room temperature (do not freeze)
- tamper evident, do not use any opened or torn packets
Inactive Ingredients
cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolatum, phenoxyethanol, water
Questions Or Comments?
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