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| Product NDC Code | 0132-0324 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Boudreauxs |
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| Type | Brand | ||||||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | OINTMENT | ||||||||
| RxCUI drug identifier | 708071 | ||||||||
| Application Number | M016 | ||||||||
| Labeler Name | C.B. Fleet Company, 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 Zinc oxide, 16%
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 Change wet and soiled diaper immediately Cleanse the diaper area and allow to dry Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients mineral oil, paraffin, petrolatum, ricinus communis (castor) seed oil Dist by C. B. Fleet Company, Inc. Tarrytown, NY 10591 A Prestige Consumer Healthcare company © 2019 Trade dress is owned by C.B. Fleet company Inc. All rights reserved. Made in USA
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 treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness
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.Boudreauxs Zinc Oxide ZINC OXIDE ZINC CATION MINERAL OIL PARAFFIN PETROLATUM CASTOR OIL
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 TREATS & PROTECTS Boudreaux’s® Butt Paste Diaper rash ointment Skin protectant /16% zinc oxide Sensitive Skin NET WT. 4 OZ (113 g) TREATS & PROTECTS Boudreaux’s® Butt Paste Diaper rash ointment Skin protectant /16% zinc oxide Sensitive Skin NET WT. 4 OZ (113 g)
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
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, seek medical help or call poison control center (1-800-222-1222)
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 15-25⁰ C (59-77⁰ F) Remove foil seal from tube’s tip before use For use with infants, children and adults Will stain clothing and fabric
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 or does not improve after 7 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 avoid contact with the 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 F o r external use only When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens or does not improve after 7 days Keep out of reach of children If swallowed, seek medical help or call poison control center (1-800-222-1222)
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