NDC 74658-005 Miniso Hand Sanitizer

Hand Sanitizer

NDC Product Code 74658-005

NDC 74658-005-01

Package Description: 50 mL in 1 BOTTLE

NDC 74658-005-02

Package Description: 60 mL in 1 TUBE

NDC 74658-005-03

Package Description: 236 mL in 1 BOTTLE, PUMP

NDC 74658-005-04

Package Description: 236 mL in 1 BOTTLE

NDC 74658-005-05

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC 74658-005-06

Package Description: 950 mL in 1 BOTTLE, PUMP

NDC Product Information

Miniso Hand Sanitizer with NDC 74658-005 is a a human over the counter drug product labeled by Guangzhou Xuelei Cosmetic Co.,ltd.. The generic name of Miniso Hand Sanitizer is hand sanitizer. The product's dosage form is gel and is administered via topical form.

Labeler Name: Guangzhou Xuelei Cosmetic Co.,ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Miniso Hand Sanitizer Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALCOHOL 75 mL/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Guangzhou Xuelei Cosmetic Co.,ltd.
Labeler Code: 74658
FDA Application Number: part333A 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: 05-04-2020 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.

Miniso Hand Sanitizer Product Label Images

Miniso Hand Sanitizer 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

Active Ingredients:

Ethyl Alcohol 75%

Purpose

Antiseptic skin cleaner

Uses:

Antiseptic skin cleaner. Kills harmful bacteria germs.

Warnings:

For external use only.When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care professional if irritation develops.Keep out of reach of children. If swallowed, call a poison centre or get medical help right away.Flammability warning: Keep away from open flame and sources of heat.

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care professional if irritation develops.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, call a poison centre or get medical help right away.

Contraindications:

Do not use on children/infants less than 2 years of age (unless directed by a doctor/physician/health care practitioner/health care provider/health care professional).

Directions:

For occasional and personal domestic use. Supervise children when they use this product. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Storage:

Flammable. Avoid direct sunlight and keep away from fire. Store below 110 (degrees fahrenheit). May cause discoloration to certain fabrics and surface.

Inactive Ingredients:

Water (AQUA), Carbomer, Triethanolamine.

Package Label

MINISOHAND SANITIZER (50ml)SCENT FREESHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLYKEEPS YOUR HANDS CLEAN & HYDRATED50ml e (1.7 fl.oz.)

MINISOHAND SANITIZER (60ml)SCENT FREESHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLYKEEPS YOUR HANDS CLEAN & HYDRATED60ml e (2.0 fl.oz.)

MINISOHAND SANITIZER (236ml)SCENT FREESHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLYKEEPS YOUR HANDS CLEAN & HYDRATED236ml e (8 fl.oz.)

MINISOHAND SANITIZER (236ml)SCENT FREESHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLYKEEPS YOUR HANDS CLEAN & HYDRATED236ml e (8 fl.oz.)

MINISOHAND SANITIZER (500ml)SCENT FREESHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLYKEEPS YOUR HANDS CLEAN & HYDRATED500ml e (17 fl.oz.)

MINISOHAND SANITIZER (950ml)SCENT FREESHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLYKEEPS YOUR HANDS CLEAN & HYDRATED950ml e (32.3 fl.oz.)

* Please review the disclaimer below.