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| Product NDC Code | 57337-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Oatmeal skin relief calming . 8oz |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 891710 | ||||
| Application Number | part347 | ||||
| Labeler Name | Rejoice International 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 Ingredient Dimethicone 1.3%
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 liberally as often as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Petrolatum, Cetyl Alcohol, Glyceryl Stearate, Propylene Glycol, Glycerin, Stearyl Alcohol, PEG-100 Stearate, Polyacrylamide, DMDM Hydrantoin, Isopropyl Myristate, Fragrance, C13-14 Isoparaffin, Laureth-7, Avena Sativa (Oat) Kernel Extract, Disodium EDTA, Methylparaben, Propylparaben
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.Use Help prevent and temporarily protects chafed, chapped, or cracked skin.
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.Oatmeal Skin Relief Calming . 8oz Dimethicone CETYL ALCOHOL ISOPROPYL MYRISTATE LAURETH-7 MAGNESIUM DISODIUM EDTA POLYACRYLAMIDE (10000 MW) C13-14 ISOPARAFFIN CETYL STEARATE PEG-100 STEARATE DMDM HYDANTOIN METHYLPARABEN WATER PETROLATUM GLYCERIN PROPYLENE GLYCOL STEARYL ALCOHOL DIMETHICONE DIMETHICONE OAT KERNEL OIL DISTEARYLDIMONIUM CHLORIDE DISTEARYLDIMONIUM
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.label
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 immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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 avoid contact with eyes. In case of eye contact, flush with water. Do not use on Deep or puncture wounds Animal bites Serious burns Stop use and ask a doctor if conditions worsens. Symptoms last more than 7 days or clear up and occur again within a few days.
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