NDC 78887-001 Antibacterial Hand Sanitizer

Alcohol

NDC Product Code 78887-001

NDC 78887-001-01

Package Description: 29 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-02

Package Description: 59 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-03

Package Description: 100 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-04

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-05

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-06

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-07

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-08

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-09

Package Description: 887 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-10

Package Description: 946 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-11

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-12

Package Description: 2000 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-13

Package Description: 3000 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-14

Package Description: 3800 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-15

Package Description: 4000 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-16

Package Description: 5000 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-17

Package Description: 7600 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-18

Package Description: 10000 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-19

Package Description: 11400 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-20

Package Description: 18900 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-21

Package Description: 20000 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-22

Package Description: 37900 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-23

Package Description: 50000 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-24

Package Description: 100000 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-25

Package Description: 150000 mL in 1 BOTTLE, PLASTIC

NDC 78887-001-26

Package Description: 200000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Antibacterial Hand Sanitizer with NDC 78887-001 is a a human over the counter drug product labeled by Ankit Llc. The generic name of Antibacterial Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Ankit Llc

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.

Antibacterial 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)
  • 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.

Product Labeler Information

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

Labeler Name: Ankit Llc
Labeler Code: 78887
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: 06-13-2020 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.

Antibacterial Hand Sanitizer Product Label Images

Antibacterial 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

Alcohol 75% v/v.

Purpose

Antiseptic

Uses

Eliminate bacteria and viral matter on the skin.

Warnings

  • Do not useon children under 2 months of ageon open woundsWhen using:Avoid contact with face. eyes. and broken skin. In case of eye contact, flush with clean water and seek medical assistance.Stop use and contact a doctor if:Irritation or redness occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of ingestion. seek medical help or contact a Poison Control Center immediately.

Directions

  • Dispense a liberal amount of product on hands, enough to coat palms and fingers and then rub until dry.Supervise small children to ensure proper usage and prevent ingestion.

Other Information

  • Store below 110°F[43°C].May discolor certain fabrics/surfaces.

Inactive Ingredients

Water, Aloe, Carbomer, Triethanolamine.

* Please review the disclaimer below.