Chapstick 12 Days Of Christmas
White Petrolatum
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0135-2029Chapstick 12 Days Of Christmas also known as White Petrolatum is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Chapstick 12 Days Of Christmas is 0135-2029. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Chapstick 12 Days Of Christmas drug includes . The currest status of Chapstick 12 Days Of Christmas drug is Active.
Drug Information:
| Drug NDC: | 0135-2029 |
| 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: | Chapstick 12 Days Of Christmas |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Chapstick |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | 12 Days of Christmas |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | White Petrolatum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| 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: | |
| 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: | 30 Sep, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| 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, 2024 |
| 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: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| 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 |
|---|
| 0135-2029-01 | 1 KIT in 1 PACKAGE (0135-2029-01) * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 1 CYLINDER in 1 BLISTER PACK (0573-0705-12) / 4 g in 1 CYLINDER * 1 CYLINDER in 1 BLISTER PACK (0573-0701-12) / 4 g in 1 CYLINDER | 30 Sep, 2021 | 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
Product Elements:
Chapstick 12 days of christmas white petrolatum chapstick classic original white petrolatum petrolatum petrolatum camphor (natural) carnauba wax cetyl alcohol isopropyl myristate lanolin light mineral oil octyldodecanol oleyl alcohol paraffin phenyl trimethicone d&c red no. 6 titanium dioxide white wax fd&c yellow no. 5 chapstick classic cherry white petrolatum petrolatum petrolatum arachidyl propionate camphor (natural) carnauba wax cetyl alcohol isopropyl myristate lanolin light mineral oil levomenthol octyldodecanol paraffin phenyl trimethicone d&c red no. 6 saccharin white wax chapstick clover honey cosmetic chapstick cake batter cosmetic chapstick cotton candy cosmetic chapstick passion fruit cosmetic chapstick holiday cocoa cosmetic chapstick vanilla latte cosmetic chapstick pumpkin pie cosmetic chapstick sugar cookie cosmetic chapstick candy cane cosmetic chapstick vanilla mint cosmetic
Indications and Usage:
Uses ⪠helps prevent and temporarily protects chafed, chapped or cracked lips ⪠helps prevent and protect from the drying effects of wind and cold weather
Warnings:
Warnings for external use only
Dosage and Administration:
Directions apply as needed
Package Label Principal Display Panel:
Principal display panel ndc 0573-2028-01 12 days of chapstick ® to from ⢠1 classic original skin protectant ⢠1 classic cherry skin protectant ⢠10 cosmetic lip balms 12 sticks net wt 0.15 oz (4 g) each 000065947 â front chapstick 12 days of christmas 12 ct
Further Questions:
Questions or comments? call weekdays from 9 am to 5 pm est at 1-877-227-3421