Disinfectant Wipes For Hand Sanitizing

Alcohol


Haining Lily Cleaning Products Co., Ltd
Human Otc Drug
NDC 77435-114
Disinfectant Wipes For Hand Sanitizing also known as Alcohol is a human otc drug labeled by 'Haining Lily Cleaning Products Co., Ltd'. National Drug Code (NDC) number for Disinfectant Wipes For Hand Sanitizing is 77435-114. This drug is available in dosage form of Swab. The names of the active, medicinal ingredients in Disinfectant Wipes For Hand Sanitizing drug includes Alcohol - 75 g/100g . The currest status of Disinfectant Wipes For Hand Sanitizing drug is Active.

Drug Information:

Drug NDC: 77435-114
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: Disinfectant Wipes For Hand Sanitizing
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
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Haining Lily Cleaning Products Co., Ltd
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Swab
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 g/100g
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: 05 Aug, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 04 May, 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: 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:HAINING LILY CLEANING PRODUCTS CO., LTD
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1307051
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
77435-114-0172 POUCH in 1 CANISTER (77435-114-01) / 3.5 g in 1 POUCH05 Aug, 2020N/ANo
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 antiseptic

Product Elements:

Disinfectant wipes for hand sanitizing alcohol alcohol alcohol water

Indications and Usage:

Use for hand sanitizing

Warnings:

Warning flammable, keep away from fire or flame. for external use only. when using this product do not use in or near the eyes. in case of contact, rinse eyes thoroughly with water. use wipes only on unbroken, intact skin if you hve sensitive skin or certain allergies, check the east of ingredients on the label bofre using wipes. do not ingest. stop use and ask a doctor if skin irritation or rednes develops. other information: do not store above 105℉ may discolor some fabriks children under 6 years of age use only under adult supvision.

Dosage and Administration:

Directions wipe hands thoroughly, let skin dry and discard. keep out of reach of children, children under 6 years of age use only under adult supervision not recommended for infants

Package Label Principal Display Panel:

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Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.