Boudreauxs Rash Kicking Kit
Zinc Oxide
C.b. Fleet Company, Inc.
Human Otc Drug
NDC 0132-0325Boudreauxs Rash Kicking Kit also known as Zinc Oxide is a human otc drug labeled by 'C.b. Fleet Company, Inc.'. National Drug Code (NDC) number for Boudreauxs Rash Kicking Kit is 0132-0325. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Boudreauxs Rash Kicking Kit drug includes . The currest status of Boudreauxs Rash Kicking Kit drug is Active.
Drug Information:
| Drug NDC: | 0132-0325 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Boudreauxs Rash Kicking Kit |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | C.b. Fleet Company, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 25 May, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part347 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | C.B. Fleet Company, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0132-0325-01 | 1 KIT in 1 CARTON (0132-0325-01) * 1 TUBE in 1 CARTON / 57 g in 1 TUBE * 1 TUBE in 1 CARTON / 57 g in 1 TUBE | 25 May, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose skin protectant
Purpose skin protectant
Product Elements:
Boudreauxs rash kicking kit zinc oxide boudreauxs zinc oxide zinc oxide zinc oxide balsam peru castor oil mineral oil paraffin petrolatum beige boudreauxs zinc oxide zinc oxide zinc oxide balsam peru castor oil mineral oil paraffin petrolatum beige
Indications and Usage:
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
Warnings:
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 ke ep out of the reach of children to prevent accidental ingestion 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 ke ep out of the reach of children to prevent accidental ingestion if swallowed, seek medical help or call poison control center (1-800-222-1222) immediately
When Using:
When using this product avoid contact with the eyes
When using this product avoid contact with the eyes
Dosage and Administration:
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
Stop Use:
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
Package Label Principal Display Panel:
Principal display panel boudreauxâs® rash kicking⢠kit kit includes: -original boudreauxâs butt paste®-net wt. 2oz (57 g) -maximum strength boudreauxâs butt paste®- net wt. 2oz (57 g) -boudreauxâs butt brush⢠boudreauxâs® rash kicking⢠kit kit includes: -original boudreauxâs butt paste®-net wt. 2oz (57 g) -maximum strength boudreauxâs butt paste®- net wt. 2oz (57 g) -boudreauxâs butt brushâ¢
Further Questions:
Questions or comments 1-855-785-2888 www.buttpaste.com max strength boudreauxâs butt paste ® diaper rash ointment skin protectant (zinc oxide) drug facts
Questions or comments 1-855-785-2888 www.buttpaste.com boudreauxâs® butt brush diaper cream applicator bpa free silicone instructions: step 1: apply butt paste® on brush head. step 2: gently brush butt paste® on babyâs 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 boudreauxâs butt brush⢠is not a toy. use only as directed. discontinue use if skin shows signs of sensitivity or irritation towards the boudreauxâs butt brushâ¢. discard or sterilize the boudreauxâs butt brush⢠in boiling water if comes in contact with yeast infected skin or an infectious rash.