Hydrocortisone 1% Cream
FDA Label NDC 69396-081
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Hydrocortisone 1% (NDC 69396-081). 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 drug facts, active ingredient, purpose, uses, when using this product, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-Itch
Uses
temporary relieves external anal itching.
temporary relief of itching associated with minor skin irritations and rashes
other uses of this product should be only under the advice and supervision of a doctor
When Using This Product
Avoid Contact with eyes
do not exceed the recommended daily dosage unless directed by a doctor
do not put into the rectum by using fingers or any mechanical device or applicator
Warnings
for external use only
Directions
●Adults when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.
●gently dry by patting or blotting with a tissue or 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.
Inactive Ingredients
Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecanol, petrolatum, purified water, sodium dodecyl sulfate
Other Information
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2020 CVS Pharmacy
CVS.com
1 800 Shop CVS
Made in China
V-36582
This product is not manufactured or distributed by Pfizer, distributor of Preparation H Anti-itch Cream.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222)
Stop Use And Ask A Doctor If
bleeding occurs
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 consulted a doctor.
Qustions Or Comments
Call 1 800 296-9067
Do Not Use
Do not use for the treatment of Diaper Rash. Consult Doctor.
* Please review the disclaimer below.
