FDA Label for Hydrocortisone 1%
View Indications, Usage & Precautions
Hydrocortisone 1% Product Label
The following document was submitted to the FDA by the labeler of this product Trifecta Pharmaceuticals Usa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-Itch
Uses
For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps
● detergents ● cosmetics ● jewelry ● external feminine genital and anal itching
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 the treatment of a diaper rash, consult with doctor
For external genital itching if you have a vaginal discharge, consult doctor
When Using This Product
- Avoid Contact with the eyes
- Do not begin the use of any other hydrocortisone product unless you have consulted a doctor
- For external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use and consult a doctor.
- do not put this product into the rectum by using fingers or any medicated device or applicator.
Stop Using This Product And Ask A Doctor If
- conditions worsen
- symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
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.
For External and anal itching:
Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
Children: under 12 years of age with external anal itching: consult a doctor.
Inactive Ingredients
Ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecanol, petrolatum, purified water, sodium dodecyl sulfate
Other Information
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)
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