Hydrocortisone
FDA Label NDC 50607-5802

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by B8 Sales, Inc. for the product Hydrocortisone (NDC 50607-5802). 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 other, active ingredient, purpose, uses, warnings, ask a doctor before use:, when using this product, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Ask A Doctor Before Use:

→ When Using This Product

→ Do Not Use

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Other

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes

25 Packets

Each Packet Net.Wt.0.9gm

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only
Do not use for the treatment of diaper rash
not for external genital, feminine and anal itching

Ask A Doctor Before Use:

for external itching, do not exceed the recommended daily dosage, or if bleeding occurs
if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

When Using This Product

avoid contact with eyes
do not put this product into rectum or vagina by using fingers or any mechanical device or applicator

Do Not Use

with any other Hydrocortisone product unless you have consulted a doctor • for feminine itching

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

for adults and children 2 years of age and older apply
to affected area 3 to 4 times daily
children under 2 years of age: do not use, consult a doctor
adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product