Hydrocortisone
FDA Label NDC 53210-1002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Morales Distributors Inc for the product Hydrocortisone (NDC 53210-1002). 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, 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

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Or Pharmacist

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Label

Active Ingredient

Hydrocortisone 1.0 percent

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
jewerly
external feminine and anal itching

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

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

butylated hydroxytoluene, cetyl alcohol, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, propylparaben, purified water, squalane, and stearic acid