Storage and handling
Other Information store at room temperature see end of carton or tube crimp for lot number and expiration date
ATOPALM Moisturizing Hydrocortisone Cream
- Manufacturer
- NeoPharm Co., Ltd.
- Effective date
- 2015-06-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 22:42:42
Label at a glance#
ProductATOPALM Moisturizing Hydrocortisone
Active ingredientHYDROCORTISONE
Label structure16 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Hydrocortisone 1%
OTC - PURPOSE SECTION
Purpose
Anti-itch
INDICATIONS & USAGE SECTION
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 SECTION
WarningsFor external use only.
OTC - ASK DOCTOR/PHARMACIST SECTION
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 SECTION
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 SECTION
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 SECTION
Ask a doctor or a pharmacist before use if you are using any other hydrocortisone product.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
Other Information
store at room temperature
see end of carton or tube crimp for lot number and expiration date
INACTIVE INGREDIENT SECTION
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 SECTION
Questions? Call 1-855-ATOPALM
SPL UNCLASSIFIED SECTION
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 4 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 4 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 4 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 4 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0857811002149 | GTIN-13: 0857811002149 EAN-13: 0857811002149 GTIN-12: 857811002149 UPC-A: 857811002149 GTIN storage (14 digits): 00857811002149 | AtopalmInner.jpg |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51141-6000-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7264-f424-e053-dadaa90a57ce | ATOPALM Moisturizing Hydrocortisone Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51141-6000-1 | ATOPALM Moisturizing Hydrocortisone | 28.3 g in 1 TUBE | CREAM | 28.3 | 4 | |
| 51141-6000-1 | ATOPALM Moisturizing Hydrocortisone | 1 in 1 CARTON | CREAM | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51141-6000 | ATOPALM MOISTURIZING HYDROCORTISONE (HYDROCORTISONE) CREAM [NEOPHARM CO., LTD.] | 4 | Legacy NDC, 2 package rows | 20150609_da9db299-c18c-4b9e-b036-c52f78e57581.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | 4 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | 4 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 4 | |
| CHOLESTEROL | INACTIVE INGREDIENT | 97C5T2UQ7J | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 4 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 4 | |
| MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA | INACTIVE INGREDIENT | 1211AIM8G7 | 4 | |
| PEG-15 GLYCERYL STEARATE | INACTIVE INGREDIENT | 91245SPD5K | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 4 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Products#
Every source-derived product name is available through these pages.
- ATOPALM Moisturizing Hydrocortisone
- HYDROCORTISONE
- WATER
- GLYCERIN
- PEG-15 GLYCERYL STEARATE
- ISOPROPYL MYRISTATE
- SQUALANE
- STEARIC ACID
- BUTYLATED HYDROXYTOLUENE
- CHOLESTEROL
- METHYLPARABEN
- PROPYLPARABEN
- MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51141-6000 | 51141-6000-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PEG-15 GLYCERYL STEARATE | 91245SPD5K | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| SQUALANE | GW89575KF9 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| CHOLESTEROL | 97C5T2UQ7J | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA | 1211AIM8G7 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / TOPICAL | 213 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| CHOLESTEROL | CHOLESTEROL | 97C5T2UQ7J | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 0.32 %w/v | ||
| CHOLESTEROL | CHOLESTEROL | 97C5T2UQ7J | CREAM / VAGINAL | 0.3 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INFILTRATION | 0.35 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION, CONCENTRATE / ORAL | 0.1 mg/1ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / VAGINAL | 3 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRALESIONAL | 0.02 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET / ORAL | 3 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | AEROSOL, FOAM / TOPICAL | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, LIQUID FILLED / ORAL | 0.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SUPPOSITORY / VAGINAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SHAMPOO / TOPICAL | 0.1 %w/w | ||
| SQUALANE | SQUALANE | GW89575KF9 | POWDER / ORAL | 0.02 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM, AUGMENTED / TOPICAL | 0.2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, FOR SUSPENSION / ORAL | 0.1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAVENOUS | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SWAB / TOPICAL | 0.5 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| SQUALANE | SQUALANE | GW89575KF9 | AEROSOL, FOAM / TOPICAL | 2.23 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 74b83355-8af7-440f-9c35-36660fc5d474 | da9db299-c18c-4b9e-b036-c52f78e57581 | 2015-06-09 | Warnings | 74b83355-8af7-440f-9c35-36660fc5d474 da9db299-c18c-4b9e-b036-c52f78e57581 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.