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| Product NDC Code | 71564-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Okeeffes eczema relief hand 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 | 1189915 | ||||
| Application Number | part347 | ||||
| Labeler Name | The Gorilla Glue Company/O'Keeffe's Company | ||||
| 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 2%
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 Water, Glycerin, Cetyl Alcohol, Isopropyl Myristate, Dimethicone, Aluminum Starch Octylsuccinate, Cetearyl Alcohol, Ceteareth-20, Polysilicone-11, Butyrospermum Parkii (Shea) Butter, Distearyldimonium Chloride, Panthenol, Allantoin, 1,2-Hexanediol, Caprylyl Glycol, Polyquaternium-10, Beeswax, Caesalpinia Spinosa Gum, Bisabolol, Disodium EDTA, Zingiber Officianale (Ginger) Root Extract, Glyceryl Stearate, PEG-100 Stearate, Laureth-4, Laureth-23, Laureth-12, Phenoxyethanol, Ethylhexyglycerin
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
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.OKeeffes Eczema Relief Hand Cream Colloidal Oatmeal CAESALPINIA SPINOSA RESIN POLYQUATERNIUM-10 (1000 MPA.S AT 2%) LEVOMENOL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) GLYCERYL MONOSTEARATE LAURETH-4 CAPRYLYL GLYCOL LAURETH-12 YELLOW WAX PEG-100 STEARATE LAURETH-23 PHENOXYETHANOL ETHYLHEXYLGLYCERIN 1,2-HEXANEDIOL EDETATE DISODIUM EDETIC ACID GINGER SHEA BUTTER ALLANTOIN WATER GLYCERIN CETYL ALCOHOL ISOPROPYL MYRISTATE DIMETHICONE ALUMINUM STARCH OCTENYLSUCCINATE CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER DISTEARYLDIMONIUM CHLORIDE DISTEARYLDIMONIUM PANTHENOL 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.NEW O'KEEFFE'S® CLINICAL | HAND ECZEMA RELIEF Hand Cream for extremely dry, itchy, irritated hands 48 HOUR ITCH RELIEF IN ONE USE Colloidal Oatmeal Skin Protectant Dermatologist Tested Steroid & Fragrance Free GUARANTEED RELIEF Net Wt. 2 oz. (57 g) Eczema Relief 2oz Hand
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
OKeeffesCompany.com Questions/Comments: 1-800-275-2718 ©2020 Distributed by: O'Keeffe's Company Cincinnati, OH 45241 Made in USA with Domestic and Imported Materials
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.
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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not get into eyes
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
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