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| Product NDC Code | 21130-898 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Oatmeal |
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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 | M016 | ||||||
| Labeler Name | Better Living Brands, LLC | ||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.adverse reaction *This product is not manufactured or distributed by Johnson & Johnson Consumer Prodcuts Company, distributor of Aveeno Active Naturals Daily Moisturizing Lotion This non-greasy, fast absorbing formula relieves dryness and can be used every day for hands and body. It is non-comedogenic and contains no added fragrance DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 1-888-723-3929 www.betterlivingbrandsLLC.com
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 as necessary
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, Avena sativa (oat) kernel flour, benzyl alcohol, sodium chloride
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 helps prevent and temporarily protects chafed, chapped, or cracked skin helps protect from the drying effects of wind and cold weather
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 Dimethicone WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL OATMEAL BENZYL ALCOHOL SODIUM CHLORIDE DIMETHICONE DIMETHICONE
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.principal display panel Signature CARE Quality Guaranteed Daily Moisturizing LOTION SKIN PROTECTANT PROTECTS & RELIEVES DRY SKIN COMPARE TO AVEENO DAILY MOISTURIZING LOTION fragrance-free non-comedogenic dermatologist tested 18 FL OZ (532 mL) image description
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on deep or puncture wounds animal bites serious burns
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