FDA Label for Sunmark Hydrocortisone
View Indications, Usage & Precautions
Sunmark Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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.
Other
Drug Facts
Distributed by McKesson
One Post Street
San Francisco, CA 94104
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-itch
Uses
for the 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 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
- avoid contact with the eyes
- 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
- in case of bleeding
- if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
- before you begin using any other hydrocortisone product
Do Not Use This Product And Ask A Doctor
- if you have a vaginal discharge
- before treating diaper rash
- before using on children under 2 years of age
For External Anal Itching Users
- do not exceed the recommended daily dosage unless directed by a doctor
- in case of bleeding, consult a doctor promptly
- do not put this product into the rectum by using fingers or any mechanical device or applicator
- children under 12 years of age: consult a doctor
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Before using any medication, read all label directions. Keep this carton. It contains important information.
Directions
- when practical, cleanse the 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 application of this product
- adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
- children under 12 years of age: Do not use, consult a doctor
Other Information
- to open: unscrew cap and pull tab to remove foil seal
- if seal has been broken, do not use this product. Return product to the store where you bought it
- store at controlled room temperature 15° – 30°C ( 59°- 86°F)
- see carton or tube crimp for lot number and expiration date
Inactive Ingredients
fractionated coconut oil, methylparaben, propylparaben, white petrolatum
Principal Display Panel - 28.4 G Tube Carton
sunmark™
hydrocortisone ointment 1%
Antipruritic (Anti-Itch)
MAXIMUM STRENGTH
NET WT 1 OZ (28.4 g)
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