Atopalm Moisturizing Hydrocortisone
FDA Label NDC 51141-6000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neopharm Co., Ltd. for the product Atopalm Moisturizing Hydrocortisone (NDC 51141-6000). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor/pharmacist, otc - when using, otc - stop use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Ask Doctor/pharmacist

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Ask Doctor

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Storage And Handling

→ Inactive Ingredient

→ Otc - Questions

→ Other

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredient
Hydrocortisone 1%

Otc - Purpose

Purpose

Anti-itch

Indications & Usage

Uses for the temporary relief or itching associated with minor skin irritation, inflammation and rashes due to:
eczema

insect bites

poison ivy, poison oak, or poison sumac
soaps
detergents

jewelry

seborrheic dermatitis

psoriasis

external genital and anal itching Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

WarningsFor external use only.

Otc - Ask Doctor/Pharmacist

Do not use

for the treatment of diaper rash. Consult a doctor

for external genital itching or if you have a vaginal discharge. Consult a doctor.

Otc - When Using

When using this product

avoid contact with the eyes
do not begin the use of any other hydrocortisone product unless you have consulted a doctor
for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.

Do not put this product in rectum by using fingers or any mechanical devise for application.

Otc - Stop Use

Stop use and ask a doctor if

condition worsens or if symptoms persist for more than 7 days or clean up and then occur again within a few days. Stop use and do not begin use of any other hydrocortisone products unless you have consulted a doctor. Do not exceed recommended daily dosage unless directed by a doctor.

Otc - Ask Doctor

Ask a doctor or a pharmacist before use if you are using any other hydrocortisone product.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions

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

Do not use. Consult a doctor.
For external anal 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 application of this product.

children under 12 years of age with external anal itching, consult a doctor.

Storage And Handling

Other Information

store at room temperature
see end of carton or tube crimp for lot number and expiration date

Inactive Ingredient

Inactive Ingredients Water, Glycerin, Cetyl Alcohol, PEG-15 Glyceryl Stearate, Glyceryl Stearate, Isopropyl Myristate, Squalane, Stearic Acid, BHT, Cholesterol, Myristoyl/Palmitoyl Oxostearamide/ Arachamide MEA, Methylparaben, Propylparaben