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Product NDC Code | 69423-700 | ||||||
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Drug Name | Olay sensitive soothing moisturizer skin protectant fragrance-free |
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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 | 1654149 | ||||||
Application Number | M016 | ||||||
Labeler Name | The Procter & Gamble Manufacturing Company | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Colloidal Oatmeal 0.5%
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.Water, glycerin, isohexadecane, niacinamide, dimethicone, isopropyl isostearate, stearyl alcohol, cetyl alcohol, hydrogenated shea butter, panthenol, palmitoyl pentapeptide-4, ethylhexylglycerin, hydroxyacetophenone, dimethiconol, C13-14 isoparaffin, cetearyl Glucoside, cetearyl alcohol, laureth-7, stearic acid, palmitic acid, behenyl alcohol, disodium EDTA, polyacrylamide, PEG-100 stearate, phenoxyethanol
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.Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free Colloidal Oatmeal PALMITIC ACID ETHYLHEXYLGLYCERIN GLYCERIN DIMETHICONOL (50000 CST) CETEARYL GLUCOSIDE ISOHEXADECANE SHEA BUTTER PALMITOYL PENTAPEPTIDE-4 LAURETH-7 NIACINAMIDE ISOPROPYL ISOSTEARATE CETYL ALCOHOL HYDROXYACETOPHENONE POLYACRYLAMIDE (1300000 MW) DIMETHICONE EDETATE DISODIUM PHENOXYETHANOL C13-14 ISOPARAFFIN WATER OATMEAL OATMEAL STEARIC ACID STEARYL ALCOHOL PANTHENOL CETOSTEARYL ALCOHOL DOCOSANOL PEG-100 STEARATE
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 - 1.70 oz (48 g) OLAY SENSITIVE SENSITIVE SOOTHING MOISTURIZER Colloidal Oatmeal Skin Protectant FRAGRANCE-FREE Net Wt. 48 g (1.7 oz) Olay
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
Manufactured in USA from local and Imported Ingredients Distr. by PROCTER & GAMBLE, CINCINNATI, OH 45202 www.olay.com
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: 1-800-285-5170
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.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. 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 swallowed, get medical help or contact a 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