Hand Sanitizer Gel
Dongguan Mingyi Medical Products Co., Ltd.
Human Otc Drug
NDC 74046-001Hand Sanitizer Gel is a human otc drug labeled by 'Dongguan Mingyi Medical Products Co., Ltd.'. National Drug Code (NDC) number for Hand Sanitizer Gel is 74046-001. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Hand Sanitizer Gel drug includes Alcohol - 75 mL/100mL . The currest status of Hand Sanitizer Gel drug is Active.
Drug Information:
| Drug NDC: | 74046-001 |
| 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: | Hand Sanitizer Gel |
| 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: | Hand Sanitizer Gel |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dongguan Mingyi Medical Products Co., Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | ALCOHOL - 75 mL/100mL
|
| 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: | 14 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | part333A |
| 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: | Dongguan Mingyi Medical Products Co., Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1305100
|
| 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: | 3K9958V90M
|
| 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 |
|---|
| 74046-001-01 | 15 mL in 1 BOTTLE (74046-001-01) | 14 Apr, 2020 | N/A | No |
| 74046-001-02 | 30 mL in 1 BOTTLE (74046-001-02) | 14 Apr, 2020 | N/A | No |
| 74046-001-03 | 40 mL in 1 BOTTLE (74046-001-03) | 14 Apr, 2020 | N/A | No |
| 74046-001-04 | 50 mL in 1 BOTTLE (74046-001-04) | 14 Apr, 2020 | N/A | No |
| 74046-001-05 | 60 mL in 1 BOTTLE (74046-001-05) | 14 Apr, 2020 | N/A | No |
| 74046-001-06 | 100 mL in 1 BOTTLE (74046-001-06) | 14 Apr, 2020 | N/A | No |
| 74046-001-07 | 236 mL in 1 BOTTLE (74046-001-07) | 14 Apr, 2020 | N/A | No |
| 74046-001-08 | 240 mL in 1 BOTTLE (74046-001-08) | 14 Apr, 2020 | N/A | No |
| 74046-001-09 | 250 mL in 1 BOTTLE (74046-001-09) | 14 Apr, 2020 | N/A | No |
| 74046-001-10 | 500 mL in 1 BOTTLE (74046-001-10) | 14 Apr, 2020 | N/A | No |
| 74046-001-11 | 3 mL in 1 BOTTLE (74046-001-11) | 14 Apr, 2020 | N/A | No |
| 74046-001-12 | 10 mL in 1 BOTTLE (74046-001-12) | 14 Apr, 2020 | N/A | No |
| 74046-001-13 | 20 mL in 1 BOTTLE (74046-001-13) | 14 Apr, 2020 | N/A | No |
| 74046-001-14 | 38 mL in 1 BOTTLE (74046-001-14) | 14 Apr, 2020 | N/A | No |
| 74046-001-15 | 45 mL in 1 BOTTLE (74046-001-15) | 14 Apr, 2020 | N/A | No |
| 74046-001-16 | 70 mL in 1 BOTTLE (74046-001-16) | 14 Apr, 2020 | N/A | No |
| 74046-001-17 | 80 mL in 1 BOTTLE (74046-001-17) | 14 Apr, 2020 | N/A | No |
| 74046-001-18 | 120 mL in 1 BOTTLE (74046-001-18) | 14 Apr, 2020 | N/A | No |
| 74046-001-19 | 300 mL in 1 BOTTLE (74046-001-19) | 14 Apr, 2020 | N/A | No |
| 74046-001-20 | 450 mL in 1 BOTTLE (74046-001-20) | 14 Apr, 2020 | 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:
âpurpose
Product Elements:
Hand sanitizer gel hand sanitizer gel water trolamine acrylic acid alcohol alcohol glycerin carbomer homopolymer, unspecified type propylene glycol
Indications and Usage:
âuses hand sanitizer to help reduce bacteria on skin.
Warnings:
Warnings for external use only.keep out of reach of children.children must be supervised if using this product. flammable.keep away from fire or flame. avoid contact with eyes.discontinue use if irritation or redness occurs.if irritation continues for more than 72hrs, please consult a doctor.
Do Not Use:
Warnings for external use only.keep out of reach of children.children must be supervised if using this product. flammable.keep away from fire or flame. avoid contact with eyes.discontinue use if irritation or redness occurs.if irritation continues for more than 72hrs, please consult a doctor.
When Using:
Dosage and Administration:
Directions place enough in your palm to thoroughly spread on both and rub into the skin until dry. children under 6 years of age should be supervised when using this product.
Stop Use:
Package Label Principal Display Panel:
Package label - principal display panel 74046-001-17 80ml 74046-001-12 10ml 74046-001-18 120ml 74046-001-16 70ml 74046-001-20 450ml 74046-001-19 300ml 74046-001-11 3ml 74046-001-14 38ml 74046-001-13 20ml 74046-001-15 45ml 15 ml label 30 ml label 40 ml label 50 ml label 60 ml label 100 ml label 236 ml label 240 ml label 250 ml label 500 ml label