NDC 52903-502 Instant Hand Sanitizer

Hand Sanitizer

NDC Product Code 52903-502

NDC 52903-502-91

Package Description: 2 BOTTLE in 1 BOX > 1 LIQUID in 1 BOTTLE (52903-502-01)

NDC Product Information

Instant Hand Sanitizer with NDC 52903-502 is a a human over the counter drug product labeled by Ningbo Pasco United Industry Co., Ltd. The generic name of Instant Hand Sanitizer is hand sanitizer. The product's dosage form is liquid and is administered via extracorporeal form.

Labeler Name: Ningbo Pasco United Industry Co., Ltd

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Instant 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 .7 1/1

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.

  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • WATER (UNII: 059QF0KO0R)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Administration Route(s)

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

  • Extracorporeal - Administration outside of the body.
  • Extracorporeal - Administration outside of the body.

Product Labeler Information

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

Labeler Name: Ningbo Pasco United Industry Co., Ltd
Labeler Code: 52903
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: 05-08-2020 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.

Instant Hand Sanitizer Product Label Images

Instant 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(S)

Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanizier to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

Otc - When Using

When using this product do not use in or near the eyes. Incase of contact, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

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

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.Children under 6 years of age should be supervised when using.

Other Information

  • Store below 110℉(43℃)May discolor certain fabrics or surfaces.

Inactive Ingredients

Water, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Glycerin, Propylene Glycol, Isopropy Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance(Parfum)

* Please review the disclaimer below.