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| Product NDC Code | 53462-915 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Comfort shield barrier |
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| Type | Brand | ||||||||||||
| Pharm Class | Skin Barrier Activity [PE] | ||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | CLOTH | ||||||||||||
| RxCUI drug identifier | 968663, 1088604 |
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| Application Number | M016 | ||||||||||||
| Labeler Name | Sage Products 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 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 remove wet and soiled garment cleanse soiled area using a fresh barrier cream cloth discard cloth after use - DO NOT FLUSH CLOTHS use as often as necessary, especially if prolonged exposure to wetness is anticipated for individual use only reseal label between uses discard package immediately if cloths are dry If warming is desired: peel open label without completely removing it heat entire package in microwave no longer than [see package for time]. since microwave wattage varies, adjust heating time accordingly Comfort Shield® may also be used at room temperature or warmed in a Comfort Personal Cleansing Warmer. Caution: If there is any indication barrier cloths are excessively hot, do not use Remember, gloves diminish your sensitivity to heat Closely monitor heat level with infants, unresponsive or skin sensitive individuals
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, glyceryl stearate, PEG-100 stearate, isopropyl palmitate, cetyl alcohol, glycerin, stearyl alcohol, phenoxyethanol, methylpropanediol, chlorhexidine gluconate, hydroxyethyl cellulose, ethylhexylglycerin, polyquaternium-37, propylene glycol dicaprylate/dicaprate, glucono-delta-lactone, PPG-1 trideceth-6 Barrier cloths: cellulose fiber/polyester (PET) fiber
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 seal out wetness helps treat and prevent perineal dermatitis protects from minor skin irritation associated with perineal dermatitis
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.Comfort Shield Barrier dimethicone WATER GLYCERYL MONOSTEARATE PEG-100 STEARATE ISOPROPYL PALMITATE CETYL ALCOHOL GLYCERIN STEARYL ALCOHOL PHENOXYETHANOL METHYLPROPANEDIOL CHLORHEXIDINE GLUCONATE HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) ETHYLHEXYLGLYCERIN POLYQUATERNIUM-37 (25000 MPA.S) PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE GLUCONOLACTONE PPG-1 TRIDECETH-6 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.Comfort Shield Barrier R4157N_7905 R5474B_Shield R5545_7905 R5549_7503 R6223B_7924 R5548_7502 R6110C_Shield R5567C_7924
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 or Comments? 800-323-2220
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 consult a doctor if condition worsens or does not improve within 7 days
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 perineal use only. Avoid contact with the eyes. Stop use and consult a doctor if condition worsens or does not improve within 7 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