NDC 73797-110 Creme21 Ultra Protect Travel Kit

Alcohol, Benzalkonium Chloride

NDC Product Code 73797-110

NDC 73797-110-04

Package Description: 1 KIT in 1 KIT * 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)

NDC Product Information

Creme21 Ultra Protect Travel Kit with NDC 73797-110 is a a human over the counter drug product labeled by Creme 21 Gmbh. The generic name of Creme21 Ultra Protect Travel Kit is alcohol, benzalkonium chloride. The product's dosage form is kit and is administered via form.

Labeler Name: Creme 21 Gmbh

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Creme 21 Gmbh
Labeler Code: 73797
FDA Application Number: part333E What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 08-27-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Creme21 Ultra Protect Travel Kit Product Label Images

Creme21 Ultra Protect Travel Kit Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Creme21 Advanced Moisturizing Hand SanitizerAlcohol 70% v/v.........antimicrobialCreme21 Advanced Moisturizing Sanitizer SprayAlcohol 70% v/v.........antimicrobialCreme21 Wet WipesBenzalkonium chloride 0.1%.....antimicrobial

Otc - Do Not Use

Creme21 Advanced Moisturizing Hand SanitizerDo not use

In children less than 2 months of age

On open skin wounds
Creme21 Advanced Moisturizing Sanitizer SprayDo not use

In children less than 2 months of age

On open skin wounds
Creme21 Wet WipesDo not use

In children less than 2 months of age

On open skin wounds

Otc - Keep Out Of Reach Of Children

Creme21 Advanced Moisturizing Hand SanitizerKeep out of children. If swallowed, get medical help or contact a poison control centre right away.Creme21 Advanced Moisturizing Sanitizer SprayKeep out of children. If swallowed, get medical help or contact a poison control centre right away.Creme21 Wet WipesKeep out of children. If swallowed, get medical help or contact a poison control centre right away

Otc - When Using

Creme21 Advanced Moisturizing Hand SanitizerWhen 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 SprayWhen using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.Creme21 Wet WipesWhen using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Otc - Stop Use

Creme21 Advanced Moisturizing Hand SanitizerStop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.Creme21 Advanced Moisturizing Sanitizer SprayStop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.Creme21 Wet WipesStop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

Other Safety Information

Creme21 Advanced Moisturizing Hand Sanitizer​Store between 15 to 30°C (59 to 86° F), Avoid freezing and excessive heat above 40°C (104° F)Creme21 Advanced Moisturizing Sanitizer Spray​Store between 15 to 30°C (59 to 86° F), Avoid freezing and excessive heat above 40°C (104° F)Creme21 Wet WipesStore at room temperature.

Warnings

Creme21 Advanced Moisturizing Hand SanitizerFor external use only. Flammable. Keep away from heat or flame.Creme21 Advanced Moisturizing Sanitizer SprayFor external use only. Flammable. Keep away from heat or flame.Creme21 Wet WipesFor external use only.

Inactive Ingredient

Creme21 Advanced Moisturizing Hand SanitizerAqua (water), Aloe barbadensis leaf extract, Carbomer, Fragrance, Glycerin, Melia azadirachta leafextract, Polysorbate 20, Triethanolamine, Tocopherol.Creme21 Advanced Moisturizing Sanitizer SprayAqua (water), Aloe barbadensis leaf extract, Fragrance, Glycerin, Melia azadirachta leafextract, Polysorbate 20, TocopherolCreme21 Wet WipesAqua (Water), Aloe Barbadensis leaf Extract, Cetylpyridinium Chloride, Citric Acid, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 20, Sodium Benzoate, Sodium Hydroxide.

Otc - Purpose

Creme21 Advanced Moisturizing Hand SanitizerUSES: Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.Creme21 Advanced Moisturizing Sanitizer SprayUSES: Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.Creme21 Wet WipesUSES: To decrease bacteria on the skin that potentially can cause disease. For use when soap and water are not available.

Indications & Usage

Creme21 Advanced Moisturizing Hand SanitizerUSES: Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.Creme21 Advanced Moisturizing Sanitizer SprayUSES: Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.Creme21 Wet WipesUSES: To decrease bacteria on the skin that potentially can cause disease. For use when soap and water are not available.

Dosage & Administration

Creme21 Advanced Moisturizing Hand SanitizerPlace 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 SprayPlace 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 WipesWet 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.

* Please review the disclaimer below.