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| Product NDC Code | 61924-410 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Renew dimethicone skin protectant |
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| Type | Brand | ||||||
| Pharm Class | Skin Barrier Activity [PE] | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M016 | ||||||
| Labeler Name | Dermarite Industries 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: Dimethicone 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: Clean skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply as necessary. If applying to perineal area, apply after each incontinent episode or diaper change to promote comfort and long lasting protection.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe Barbadensis Leaf Juice, Aluminum Stearate, Cera Alba, Cholecalciferol, Chloroxylenol, Corn Oil, Imidiazolidinyl Urea, Dicocoyl Pentaerythrityl Distearyl Citrate, Fragrance, Lanolin, Methylparaben, Mineral Oil, Paraffin wax, Petrolatum, Phenoxyethanol, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate, Tocopheryl Acetate, Water.
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: Forms a moisture barrier that prevents and helps treat effects associated with diaper rash from wetness, urine, or stool. Temporarily protects and helps relieve 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.Renew Dimethicone Skin Protectant Skin Protectant ALOE VERA LEAF ASCORBYL PALMITATE BUTYLPARABEN CANOLA OIL CARBOMER 940 CETOSTEARYL ALCOHOL CHOLECALCIFEROL ETHYLPARABEN GLYCERIN GLYCERYL MONOSTEARATE ISOBUTYLPARABEN METHYLPARABEN NIACINAMIDE OLIVE OIL PEG-100 STEARATE PHENOXYETHANOL PROPYLENE GLYCOL PROPYLPARABEN PYRIDOXINE HYDROCHLORIDE VITAMIN A PALMITATE STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE TROLAMINE EDETATE DISODIUM WATER CORN OIL 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.Renew Skin Protectant Package Label Principal Display Panel Renew Dimethicone Skin Protectant tube label Renew Dimethicone Skin Protectant 4ox box 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.Warnings: Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.
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 (59 o - 86 o F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-37-6296
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. Avoid contact with eyes. In case of contact, flush thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve within 7 days. Do not use on deep or punctured wounds.
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