Zylotrol Plus
Lidocaine 4%, Menthol 1%, Isopropyl Alcohol
Whitestone Products Llc
Human Otc Drug
NDC 81902-202Zylotrol Plus also known as Lidocaine 4%, Menthol 1%, Isopropyl Alcohol is a human otc drug labeled by 'Whitestone Products Llc'. National Drug Code (NDC) number for Zylotrol Plus is 81902-202. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Zylotrol Plus drug includes . The currest status of Zylotrol Plus drug is Active.
Drug Information:
| Drug NDC: | 81902-202 |
| 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: | Zylotrol Plus |
| 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: | Lidocaine 4%, Menthol 1%, Isopropyl Alcohol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Whitestone Products 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: | 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 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: | 15 Oct, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Jun, 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: | part348 |
| 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: | Whitestone Products LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 797544
1249758
|
| 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 |
|---|
| 81902-202-15 | 1 KIT in 1 CARTON (81902-202-15) * 1 g in 1 PATCH * 1 mL in 1 PACKET | 15 Oct, 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:
Topical anesthetic external analgesic
Purpose first aid antiseptic
Product Elements:
Zylotrol plus lidocaine 4%, menthol 1%, isopropyl alcohol lidocaine, menthol lidocaine, menthol water glycerin propylene glycol polysorbate 80 tartaric acid dihydroxyaluminum aminoacetate methylparaben lidocaine lidocaine menthol menthol isopropyl alcohol isopropyl alcohol water isopropyl alcohol isopropyl alcohol
Indications and Usage:
Uses: for temporary relief of pain
Use for preparation of the skin prior to an injection
Warnings:
Warnings: for external use only. avoid contact with eyes. if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. do not use in large quantities, particularly over raw surfaces or blistered areas. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only flammable, keep away from fire or flame
Do Not Use:
Warnings: for external use only. avoid contact with eyes. if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. do not use in large quantities, particularly over raw surfaces or blistered areas. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only flammable, keep away from fire or flame
Dosage and Administration:
Directions (adults and children over 12 years): clean and dry affected area. remove patch from backing and apply to affected area. use only one patch at a time, and maximum of four patches / day. leave patch on affected area for up to 8 hours do not use patches for longer than five consecutive days, children under 12 should consult physician prior to use.
Directions open packet remove pad apply topically as needed to cleanse intended area. discard after single use.
Stop Use:
Stop use if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.
Package Label Principal Display Panel:
Principal display panel ndc: 81902-202-15 zylotrol tm plus pacakge contains: 15 lidocaine 4%/ menthol 1% topical analgesic patches 15 isopropyl alcohol 70% prep pads principal display panel