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 Geri-care Pharmaceuticals, Corp. 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
Antipruritic (Anti-Itch)
Uses
For temporary relief of itching associated with minor skin irritations and rashes
● external feminine, genital and anal itching
Other uses of this product should be only under the advice and supervision of a doctor
Do Not Use
- For the treatment of diaper rash, consult a doctor.
- With any other Hydrocortisone product unless you have consulted a doctor
- If you have a vaginal discharge, consult a doctor
Warnings
For external use only
When Using This Product
- Avoid Contact with the eyes
- do not exceed the recommended daily dosage unless directed by a doctor.
- do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Using This Product And Ask A Doctor If
- conditions worsens, symptoms persist for more than 7 days or symptoms clear up and reappear 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.
- Rectal bleeding occurs
Directions
For Itching or skin irritation, inflammation, and rashes:
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 and ask a doctor.
For External and anal itching in adults:
When practical, clean affected area with mild soap and warm water and rinse thoroughly
Gently dry by patting or blotting with toilet tissue or a soft cloth before applying
apply to affected area not more than 3 to 4 times daily.
For children under 12 years of age: Ask a doctor
Inactive Ingredients
Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, mineral oil, petrolatum, Phenoxyethanol, water.
Other Information
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)
Tamper evident, do not use if packet is torn, cut or opened.
Avoid excessive heat and humidity.
Questions
Call 1-800-540-3765
Distributed By
Distributed By
Geri-Care Pharmaceuticals Corp
1295 Towbin Ave.
Lakewood, NJ 08701
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