FDA Label for Hydrocortisone
View Indications, Usage & Precautions
Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Safetec Of America, Inc.. 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.
Other
Drug Facts
Active Ingredients
Hydrocortisone USP 1%
Purpose
Antipruritic (Anti-itch)
Uses
For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching
Warnings
For external use only
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Do Not Use
- In the eyes
- For diaper rash
- For external genital or feminine itching if you have a vaginal discharge
- More than the recommended daily dosage unless directed by a doctor
- This product in the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- Condition worsens, symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor
- In case of bleeding when used for anal itching
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
Directions
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor
- When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching
Other Information
- Store at room temperature
- Avoid excessive heat
Inactive Ingredients
Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Soft Paraffin
Principal Display Panel - 1 Oz. Tube Label
Safetec®
1% Hydrocortisone Cream
For Itching, Inflammation, and Rashes
Net Wt. 1oz. (28.4g)
Reorder No. 53111
Manufactured for: Safetec of America, Inc.
Buffalo, NY 14215 | 1-800-456-7077
Made In India KD/503
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