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| Product NDC Code | 72812-151 | ||||
|---|---|---|---|---|---|
| Drug Name | Earth mama eczema cream |
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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 | 1595494 | ||||
| Application Number | part347 | ||||
| Labeler Name | Earth Mama Angel Baby, LLC | ||||
| 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 Ingredient Colloidal Oatmeal* 5%
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 Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Coconut) Oil*, Caprylic/Capric Triglyceride*, Olea Europaea (Olive) Fruit Oil*, Beeswax*, Butyrospermum Parkii (Shea) Butter*, Simmondsia Chinensis (Jojoba) Seed Oil*, Oenothera Biennis (Evening Primrose) Oil*, Aloe Barbadensis Leaf Powder*, Aspalathus Linearis (Rooibos) Leaf Extract*, Nigella Sativa (Black Cumin) Seed Extract*, Tocopherol, Zinc Oxide *Organic
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. For use on mild to moderate eczema or as directed by a physician.
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.Earth Mama Eczema Cream Colloidal Oatmeal OATMEAL OATMEAL SUNFLOWER OIL COCONUT OIL MEDIUM-CHAIN TRIGLYCERIDES OLIVE OIL YELLOW WAX SHEA BUTTER JOJOBA OIL EVENING PRIMROSE OIL ALOE VERA LEAF ASPALATHUS LINEARIS LEAF NIGELLA SATIVA SEED TOCOPHEROL ZINC OXIDE
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.Packaging IMAGE
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
THERAPEUTIC ITCH RELIEF Pediatrician & Dermatologist Tested Contains Organic Rooibos & Black Cumin Seed Steroid-free, NO Artificial Preservatives or Fragrance NSF contains organic ingredients FOR EVERYONE AND THEIR MOTHER. • Relieves itch on contact • Moisturizing skin protectant • Relieves itch associated with eczema flare up Distributed by Earth Mama Angel Baby ® LLC 9866 SE Empire Ct. • Clackamas, OR 97015 USA Certified to the NSF/ANSI 305 Standard by Oregon Tilth Awarded the National Eczema Association Seal of Acceptance TM Leaping Bunny Certified
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 product is swallowed, get medical help or contact 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 or comments? 503-607-0607 or earthmama.com
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature.
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 For External Use Only When using this product : • do not get into eyes 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. Keep out of reach of children . If product is swallowed, get medical help or contact Poison Control Center right away.
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