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| Product NDC Code | 0132-0327 | ||||
|---|---|---|---|---|---|
| Drug Name | Boudreauxs baby shower bundle |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| 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
Active ingredient
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
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 myroxylon pereiraie (balsam peru) resin, mineral oil, paraffin, petrolatum, ricinus communis (castor) seed oil
Inactive ingredients Alpha-tocopherol actate d- (Vitamin E acetate), castor seed oil, glyceryl hydroxystearate, and hydrogenated castor oil
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
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 Zinc oxide, 40%...................................................Skin protectant
Purpose Dimethicone, 1% ...................................................Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Boudreauxs Baby Shower Bundle Zinc oxide Boudreauxs Zinc oxide ZINC OXIDE ZINC OXIDE BALSAM PERU CASTOR OIL MINERAL OIL PARAFFIN PETROLATUM Boudreauxs zinc oxide ZINC OXIDE ZINC OXIDE BALSAM PERU CASTOR OIL MINERAL OIL PARAFFIN PETROLATUM Boudreauxs Butt Barrier Dimethicone DIMETHICONE DIMETHICONE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL HYDROXYSTEARATE HYDROGENATED CASTOR OIL 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 BOUDREAUX’S ® Baby Shower Bundle KIT INCLUDES: -Maximum Strength Boudreaux’s Butt Paste ® -NET WT. 2oz (57 g) -Maximum Strength Boudreaux’s Butt Paste ® - NET WT. 14oz (396 g) -Boudreaux’s Butt Paste Butt Barrier -NET WT. 4 oz (113 g) -Boudreaux’s Butt Brush ™ Principal display panel BOUDREAUX’S® Baby Shower Bundle KIT INCLUDES: -Maximum Strength Boudreaux’s Butt Paste® -NET WT. 2oz (57 g) -Maximum Strength Boudreaux’s Butt Paste®- NET WT. 14oz (396 g) -Boudreaux’s Butt Paste Butt Barrier -NET WT. 4 oz (113 g) -Boudreaux’s Butt Brush™
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.MAX STRENGTH BOUDREAUX’S BUTT PASTE ® DIAPER RASH OINTMENT SKIN PROTECTANT (ZINC OXIDE) 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 the reach of children. If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately.
Keep out of the reach of children. If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately.
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°C to 25°C (59°F to 77°F) Remove foil seal prior to use Use with infants, children and adults Will stain clothing and fabric
Other information Store at 15°C to 25°C (59°F to 77°F) Remove foil seal from tube’s tip before use For use with infants, children and adults
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 1-855-785-2888 www.buttpaste.com BOUDREAUX’S BUTT PASTE ® Butt Barrier Protective Ointment SKIN PROTECTANT (DIMETHICONE) Drug Facts
Questions or comments 1-855-785-2888 www.buttpaste.com BOUDREAUX’S ® BUTT BRUSH DIAPER CREAM APPLICATOR BPA FREE SILICONE Instructions: Step 1: Apply Butt Paste ® on brush head. Step 2: Gently brush Butt Paste ® on baby’s bottom. For best results, apply thick coat to form a protective barrier. Step 3: Clean after each use with a baby wipe. Brush can be disinfected in boiling water as needed. It is also dishwasher safe. Suction cup sticks on almost any surface when changing the diaper. WARNING: The Boudreaux’s Butt Brush ™ is not a toy. Use only as directed. Discontinue use if skin shows signs of sensitivity or irritation towards the Boudreaux’s Butt Brush ™ . Discard or sterilize the Boudreaux’s Butt Brush ™ in boiling water if comes in contact with yeast infected skin or an infectious rash.
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.
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.
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 For 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 the reach of children. If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately.
Warnings For 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 the reach of children. If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately.
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