NDC 57337-132 Hand Sanitizer 2oz

Alcohol

NDC Product Code 57337-132

NDC 57337-132-01

Package Description: 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Hand Sanitizer 2oz with NDC 57337-132 is a a human over the counter drug product labeled by Ningbo Rejoice International. The generic name of Hand Sanitizer 2oz is alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Ningbo Rejoice International

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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 2oz 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 70 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE (UNII: V5VD430YW9)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Ningbo Rejoice International
Labeler Code: 57337
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: 09-28-2020 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 2oz Product Label Images

Hand Sanitizer 2oz 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(S)

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Use

  • For handwashing to decrease bacteria on the skinrecommended for repeated use

Warnings

For external use only: hands. Flammable, keep away from fire or flame

Otc - Stop Use

Stop use and ask a doctor if irritation or rednees develp and persist for more than 72 hours.

Otc - 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

  • Spray hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants

Other Information

  • Store at room temperaturemay discolor certain fabrics

Inactive Ingredients

Water, glycerin, fragrance, aloe barbadensis leaf juice, tocopheryl acetate,

Otc - Questions

1-855-345-5575

Otc - When Using

  • Keep out eyes. In case of contact with eyes, flush thoroughly with wateravoid contact with broken skindo not inhale or ingest

* Please review the disclaimer below.