Label: ATOPALM MOISTURIZING HYDROCORTISONE- hydrocortisone cream
Contains inactivated NDC Code(s)
NDC Code(s): 51141-6000-1
- Packager: NeoPharm Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 9, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
INDICATIONS & USAGE
Uses for the temporary relief or itching associated with minor skin irritation, inflammation and rashes due to:
poison ivy, poison oak, or poison sumac
external genital and anal itching Other uses of this product should be only under the advice and supervision of a doctor.
- ASK DOCTOR/PHARMACIST
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.
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.
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
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
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
plus US Patented Technology
MOISTURIZING HYDROCORTISONE CREAM
WITH US PATENTED M L E TECHNOLOGY
Relieves Itching and Redness Fast!
Provides Temporary Relief and Visibly Healthier Looking Skin
medicine without a prescription for temporary relief of your worst itch symptoms.
Relieves itches due to: Dry Skin, Psoriasis, Seborrheic Dermatitis, Rashes
Net Wt. 1 oz/ 28.3 g
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ATOPALM MOISTURIZING HYDROCORTISONE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51141-6000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PEG-15 GLYCERYL STEARATE (UNII: 91245SPD5K) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHOLESTEROL (UNII: 97C5T2UQ7J) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51141-6000-1 1 in 1 CARTON 1 28.3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/17/2011 Labeler - NeoPharm Co., Ltd. (965502912) Establishment Name Address ID/FEI Business Operations NeoPharm Co., Ltd. 631101883 manufacture(51141-6000)