NDC 50049-002 Hand Sanitizer

Ethyl Alcohol

NDC Product Code 50049-002

NDC 50049-002-01

Package Description: 150 BOTTLE in 1 CARTON > 45 mL in 1 BOTTLE

NDC 50049-002-02

Package Description: 100 BOTTLE in 1 CARTON > 75 mL in 1 BOTTLE

NDC 50049-002-03

Package Description: 24 BOTTLE in 1 CARTON > 187.5 mL in 1 BOTTLE

NDC 50049-002-04

Package Description: 20 BOTTLE in 1 CARTON > 375 mL in 1 BOTTLE

NDC 50049-002-05

Package Description: 18 BOTTLE in 1 CARTON > 750 mL in 1 BOTTLE

NDC 50049-002-06

Package Description: 200 BOTTLE in 1 CARTON > 22.5 mL in 1 BOTTLE

NDC 50049-002-07

Package Description: 150 BOTTLE in 1 CARTON > 37.5 mL in 1 BOTTLE

NDC 50049-002-08

Package Description: 24 BOTTLE in 1 CARTON > 112.5 mL in 1 BOTTLE

NDC 50049-002-09

Package Description: 24 BOTTLE in 1 CARTON > 135 mL in 1 BOTTLE

NDC 50049-002-10

Package Description: 24 BOTTLE in 1 CARTON > 150 mL in 1 BOTTLE

NDC 50049-002-11

Package Description: 24 BOTTLE in 1 CARTON > 225 mL in 1 BOTTLE

NDC 50049-002-12

Package Description: 24 BOTTLE in 1 CARTON > 367.5 mL in 1 BOTTLE

NDC 50049-002-13

Package Description: 12 BOTTLE in 1 CARTON > 900 mL in 1 BOTTLE

NDC 50049-002-14

Package Description: 12 BOTTLE in 1 CARTON > 1500 mL in 1 BOTTLE

NDC 50049-002-15

Package Description: 4 BOTTLE in 1 CARTON > 2835 mL in 1 BOTTLE

NDC 50049-002-16

Package Description: 4 BOTTLE in 1 CARTON > 3750 mL in 1 BOTTLE

NDC 50049-002-17

Package Description: 2 BOTTLE in 1 CARTON > 7500 mL in 1 BOTTLE

NDC 50049-002-18

Package Description: 1 BOTTLE in 1 CARTON > 18750 mL in 1 BOTTLE

NDC Product Information

Hand Sanitizer with NDC 50049-002 is a a human over the counter drug product labeled by Quanzhou Besthope Household Products Co., Ltd.. The generic name of Hand Sanitizer is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Quanzhou Besthope Household Products 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.

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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)

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: Quanzhou Besthope Household Products Co., Ltd.
Labeler Code: 50049
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: 05-08-2020 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.

Hand Sanitizer Product Label Images

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 Ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Uses

To reduce bacteria that potentially can cause disease.

Warnings

For external use only

Flammable. Keep away from fire or flame

Keep out of reach of children. If swallowed, get medical help or contact a

Poison Control Center right away

When using this product

■Keep out of eyes. In case of contact with eyes, flush thoroughly with water

■Avoid contact with open skin

H Do not inhale or ingest

Stop use and ask a doctor

If skin irritation or redness develops

Keep Out Of Reach Of Children.

Keep out of reach of children. If swallowed, get medical help or contact a

Poison Control Center right away

Directions

■Wet hands thoroughly with product and allow to dry without wiping

■Children under 6 years of age use only under adult supervision

■Not recommended for infants

Other Information

1 Do not store above 105°F

1 May discolor some fabrics

Inactive Ingredients

Alcohol, Water (Aqua), Acrylates Copolymer, Xanthan Gum, Butylene

Glycol, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract

* Please review the disclaimer below.