Active Ingredient
Hydrocortisone 1.0%
Hydrocortisone
FDA Label NDC 63941-312
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Valu Merchandisers, Co. for the product Hydrocortisone (NDC 63941-312). 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, warnings, do not use, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, 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 irritation, inflammation and rashes due to:
- eczema
- psoriasis
- seborrheic dermatitis
- poison ivy, oak, sumac
- insect bites
- soaps and detergents
- cosmetics
- jewelry
- external feminine and anal itching
Other uses of this product: ask a doctor
Warnings
For external use only
Do Not Use
- in or near the eyes
- by putting directly into the rectum by using fingers or any mechanical device or applicator
- for external feminine itching if you have a vaginal discharge
- for diaper rash: ask a doctor.
Ask A Doctor Or Pharmacist Before Use If You Are
using any other hydrocortisone product
When Using This Product
for external anal itching, do not exceed recommended daily dosage unless directed by a doctor
Stop Use And Ask A Doctor If
- condition worsens or does not improve within 7 days
- symptoms clear up and return within a few days
- rectal bleeding occurs
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply to affected area not more than 3 to 4 times daily
- for external anal itching: when practical, clean area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- children under 2 years, or children under 12 years with external anal itching: do not use, ask a doctor
Other Information
store at room temperature, protect from freezing
Inactive Ingredients
aloe vera, butylated hydroxytoulene, carbomer 940, cetyl alcohol, ethylparaben, glycerin, glyceryl stearate, propylene glycol, purified water, sodium lauryl sulfate, stearic acid, trolamine
Package Label
Best Choice Hydrocortisone Anti-Itch Cream
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