Active Ingredient
Hydrocortisone 1%
Clotrimazole 1% Cream
FDA Label NDC 87228-1010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Choice Inc for the product Clotrimazole 1% (NDC 87228-1010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, directions, warnings, stop use and ask a doctor if, keep out of reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-itch
Uses
temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
eczema
insect bites
poison ivy, oak or sumac
soaps
detergents
cosmetics
jewelry,
seborrheic dermatitis
psoriasis
temporarily relieves external anal and genital itching
Other uses of this product should only be under the advice and supervision of a doctor.
Directions
for itching of skin irritation, inflammation, and rashes:
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: ask a doctor
for external anal and genital itching, adults:
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 applying
apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor
Warnings
For external use only
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 Poison Control Center right away (1-800-222-1222).
Other Information
store between 20° - 25°C (68° - 77°F)
see carton or tube crimp for lot number and expiration date
Inactive Ingredients
Aloe oil, Cetostearyl Alcohol, Ethylparaben, Glycerin, Glyceryl Monostearate, Mineral Oil, Petrolatum, Polyoxyl lauryl ether, Purified water, Stearic Acid
Do Not Use
in the genital area if you have a vaginal discharge.
for the treatment of diaper rash, 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
Package Label.Principal Display Panel
1 (Hydrocrtisone)
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