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| Product NDC Code | 80551-301 | ||||
|---|---|---|---|---|---|
| Drug Name | Eczema relief |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 240651 | ||||
| Application Number | part347 | ||||
| Labeler Name | ACUTENS, INC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Colloidal Oatmeal 1.00%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Beeswax, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oil, Ceramide NG, Chamomilla Matricaria (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Punica Granatum (Pomegranate) Extract, Xanthan Gum.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak, or sumac insect bites
Purpose
Information about the drug product’s indications for use.PURPOSE SKIN PROTECTANT
Spl product data elements
Usually a list of ingredients in a drug product.ECZEMA RELIEF COLLOIDAL OATMEAL SHEA BUTTER ALLANTOIN ALOE VERA LEAF WATER .ALPHA.-BISABOLOL, (+)- CHAMOMILE GLUCOSAMINE SULFATE GLYCERYL CAPRYLATE SUNFLOWER OIL XANTHAN GUM CUCUMBER EMU OIL GLYCERIN GLYCERYL MONOSTEARATE GLYCERYL 1-UNDECYLENATE LICORICE POMEGRANATE CERAMIDE NG CALENDULA OFFICINALIS WHOLE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL SAFFLOWER OIL YELLOW WAX OATMEAL OATMEAL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.01b LBL_EczemaCreamLabel
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help, or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? (917) 745-3082
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.STOP USE AND ASK A DOCTOR IF condition worsens symptoms last more than 7 days or clear up and occur again within a few days
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)IF PREGNANT OR BREAST-FEEDING, ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION Protect the product in this container from excessive heat and direct sun.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS do not get into eyes. to avoid slipping, use mat in tub or shower. in some skin conditions, soaking too long may over dry.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API