FDA Label for Atopalm Moisturizing Hydrocortisone
View Indications, Usage & Precautions
- 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
Atopalm Moisturizing Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Neopharm Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Otc - Questions
Questions? Call 1-855-ATOPALM
Other
US Patent # US 6221371B1 Distributed by: NeoPharm Co., Ltd., 80 Wood Rd., #212 Camarillo, CA 93010 Made in Korea 75712 LOT and EXP.
Package Label.Principal Display Panel
Maximum Strength
plus US Patented Technology
1% Hydrocortisone
ATOPALM TM
MOISTURIZING HYDROCORTISONE CREAM
WITH US PATENTED M L E TECHNOLOGY
Relieves Itching and Redness Fast!
Provides Temporary Relief and Visibly Healthier Looking Skin
Maximum Strength
medicine without a prescription for temporary relief of your worst itch symptoms.
ATOPALM TM
Relieves itches due to: Dry Skin, Psoriasis, Seborrheic Dermatitis, Rashes
Net Wt. 1 oz/ 28.3 g
* Please review the disclaimer below.