Hydrocortisone Maximum Strength
Drug Labeling and Warnings
Drug Details [pdf]
HYDROCORTISONE- hydrocortisone cream
Preferred Pharmaceuticals, Inc
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Hydrocortisone Maximum Strength
Uses
for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
- cosmetics
- soaps
- jewelry
- insect bites
- psoriasis
- eczema
- detergents
- seborrheic dermatitis
- external genital and anal itching
- poison ivy, poison oak, or poison sumac
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.
- for external genital itching if you have vaginal discharge. Consult a doctor.
When using this product
- avoid contact with eyes
- do not use more than directed unless told to do so by a doctor
- do not put directly into 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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
- rectal bleeding occurs
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
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
- do not use. Consult a doctor.
For external 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
Other information
- store at 15° to 30°C (59° to 86°F)
- lot number and expiration date: See crimp of tube or box
You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.
Inactive ingredients
cetyl alcohol, diazolidinyl urea, isopropyl palmitate, mineral oil/lanolin alcohol, polysorbate 40, propylene glycol, propylene glycol monostearate, purified water, sorbic acid, sorbitan monopalmitate, stearyl alcohol, xanthan gum
| HYDROCORTISONE
hydrocortisone cream |
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| Labeler - Preferred Pharmaceuticals, Inc (791119022) |
| Registrant - Preferred Pharmaceuticals, Inc (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals, Inc | 791119022 | RELABEL(68788-9856) | |