NDC 76891-110 Born Basic. Anti-bac Hand Sanitizer 65 Percent

Alcohol

NDC Product Code 76891-110

NDC 76891-110-11

Package Description: 1000 mL in 1 BOTTLE, PUMP

NDC 76891-110-12

Package Description: 1000 mL in 1 BOTTLE

NDC 76891-110-13

Package Description: 1000 mL in 1 BOTTLE, DISPENSING

NDC 76891-110-14

Package Description: 500 mL in 1 BOTTLE

NDC 76891-110-15

Package Description: 236 mL in 1 BOTTLE

NDC 76891-110-16

Package Description: 280 mL in 1 BOTTLE

NDC 76891-110-17

Package Description: 2011 mL in 1 BOTTLE

NDC 76891-110-18

Package Description: 3667 mL in 1 BOTTLE

NDC 76891-110-19

Package Description: 2000 mL in 1 BOTTLE

NDC 76891-110-20

Package Description: 3780 mL in 1 BOTTLE

NDC Product Information

Born Basic. Anti-bac Hand Sanitizer 65 Percent with NDC 76891-110 is a a human over the counter drug product labeled by Scent Theory Products Llc. The generic name of Born Basic. Anti-bac Hand Sanitizer 65 Percent is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Scent Theory Products Llc

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.

Born Basic. Anti-bac Hand Sanitizer 65 Percent 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 65 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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: Scent Theory Products Llc
Labeler Code: 76891
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: 07-15-2020 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.

Born Basic. Anti-bac Hand Sanitizer 65 Percent 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 65%

Purpose

ANTISEPTIC

Uses

  • DECREASES BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE RECOMMENDED FOR REPEATED USE

Warnings

  • For external use only: handsFlammable. Keep away from fire or flame.When using this productKeep out of eyes. In case of contact with eyes flush thoroughly with water.Avoid contact with broken skin.Do not inhale or ingest.Stop use and ask a doctor ifirritation and redness developcondition persists for more than 72 hours

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.FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION.NOT RECOMMENDED FOR INFANTS.

Other Information

  • DO NOT STORE ABOVE 105°FMAY DISCOLOR SOME FABRICSHARMFUL TO WOOD FINISHES AND PLASTICS

Inactive Ingredients

WATER, GLYCERIN, PROPYLENE GLYCOL, CARBOMER, FRAGRANCE, TRIETHANOLAMINE, ALOE BARBADENSIS (ALOE VERA)

* Please review the disclaimer below.