Creme21 Ultra Protect Travel Kit
Alcohol, Benzalkonium Chloride
Creme 21 Gmbh
Human Otc Drug
NDC 73797-110Creme21 Ultra Protect Travel Kit also known as Alcohol, Benzalkonium Chloride is a human otc drug labeled by 'Creme 21 Gmbh'. National Drug Code (NDC) number for Creme21 Ultra Protect Travel Kit is 73797-110. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Creme21 Ultra Protect Travel Kit drug includes . The currest status of Creme21 Ultra Protect Travel Kit drug is Active.
Drug Information:
| Drug NDC: | 73797-110 |
| 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: | Creme21 Ultra Protect Travel 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: | Alcohol, Benzalkonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Creme 21 Gmbh |
| 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 NOT 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: | 27 Aug, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 01 Sep, 2023 |
| 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: | part333E |
| 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: | 06 May, 2026 |
| 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: | Creme 21 GmbH
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 581662
1038856
1041849
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| 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 |
|---|
| 73797-110-04 | 1 KIT in 1 KIT (73797-110-04) * 50 mL in 1 BOTTLE, PUMP (73797-112-02) * 40 mL in 1 PACKET (73797-113-03) * 50 mL in 1 BOTTLE, PLASTIC (73797-111-01) | 27 Aug, 2020 | 01 Sep, 2023 | 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:
Creme21 advanced moisturizing hand sanitizer uses: hand sanitizer to help reduce bacteria that potentially cause disease. for use when soap and water are not available. creme21 advanced moisturizing sanitizer spray uses: hand sanitizer to help reduce bacteria that potentially cause disease. for use when soap and water are not available. creme21 wet wipes uses: to decrease bacteria on the skin that potentially can cause disease. for use when soap and water are not available.
Product Elements:
Creme21 ultra protect travel kit alcohol, benzalkonium chloride creme21 advanced moisturizing hand sanitizer alcohol aloe vera leaf water carbomer 940 trolamine alcohol alcohol polysorbate 20 glycerin azadirachta indica leaf tocopherol creme21 advanced moisturizing sanitizer alcohol aloe vera leaf water polysorbate 20 tocopherol alcohol alcohol glycerin azadirachta indica leaf creme21 wet wipes benzalkonium chloride sodium hydroxide sodium benzoate dehydroacetic acid aloe vera leaf water cetylpyridinium chloride benzalkonium chloride benzalkonium glycerin anhydrous citric acid polysorbate 20 phenoxyethanol
Indications and Usage:
Creme21 advanced moisturizing hand sanitizer uses: hand sanitizer to help reduce bacteria that potentially cause disease. for use when soap and water are not available. creme21 advanced moisturizing sanitizer spray uses: hand sanitizer to help reduce bacteria that potentially cause disease. for use when soap and water are not available. creme21 wet wipes uses: to decrease bacteria on the skin that potentially can cause disease. for use when soap and water are not available.
Warnings:
Creme21 advanced moisturizing hand sanitizer for external use only. flammable. keep away from heat or flame. creme21 advanced moisturizing sanitizer spray for external use only. flammable. keep away from heat or flame. creme21 wet wipes for external use only.
Do Not Use:
Creme21 advanced moisturizing hand sanitizer for external use only. flammable. keep away from heat or flame. creme21 advanced moisturizing sanitizer spray for external use only. flammable. keep away from heat or flame. creme21 wet wipes for external use only.
When Using:
Creme21 advanced moisturizing hand sanitizer when using this product keep out of eyes, ears and mouth. in case of contact with eyes, rinse eyes thoroughly with water. creme21 advanced moisturizing sanitizer spray when using this product keep out of eyes, ears and mouth. in case of contact with eyes, rinse eyes thoroughly with water. creme21 wet wipes when using this product keep out of eyes, ears and mouth. in case of contact with eyes, rinse eyes thoroughly with water.
Dosage and Administration:
Creme21 advanced moisturizing hand sanitizer place enough products on hands to cover all surfaces. rubs hands together until dry. supervise children under 6 years of age when using this products to avoid swallowing. creme21 advanced moisturizing sanitizer spray place enough products on hands to cover all surfaces. rubs hands together until dry. supervise children under 6 years of age when using this products to avoid swallowing. creme21 wet wipes wet hands thoroughly with product and allow to dry. open peel off label, gently full it back, remove and use wipe as required. reseal back after use to avoid drying of wipes. do not flush. children under 6 years of age should be supervised when using this product.
Stop Use:
Creme21 advanced moisturizing hand sanitizer stop use and ask a doctor if irritation or rash occurs. these may be signs of serious condition. creme21 advanced moisturizing sanitizer spray stop use and ask a doctor if irritation or rash occurs. these may be signs of serious condition. creme21 wet wipes stop use and ask a doctor if irritation or rash occurs. these may be signs of serious condition.
Package Label Principal Display Panel:
Creme 21 kit label final