NDC 70708-063 Aroma Guru Antibacterial Toasted Vanilla

Antibacterial Hand Soap

NDC Product Code 70708-063

NDC 70708-063-01

Package Description: 384.45 g in 1 BOTTLE, PUMP

NDC Product Information

Aroma Guru Antibacterial Toasted Vanilla with NDC 70708-063 is a a human over the counter drug product labeled by Gurunanda Llc. The generic name of Aroma Guru Antibacterial Toasted Vanilla is antibacterial hand soap. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Gurunanda 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.

Aroma Guru Antibacterial Toasted Vanilla 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.

  • BENZALKONIUM CHLORIDE .3 g/100g

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)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

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: Gurunanda Llc
Labeler Code: 70708
Marketing Category: UNAPPROVED DRUG OTHER - 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: 10-05-2020 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.

Aroma Guru Antibacterial Toasted Vanilla Product Label Images

Aroma Guru Antibacterial Toasted Vanilla 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

Otc - Active Ingredient

Benzalkonium Chloride 0.3%

Otc - Purpose

Antibacterial

Warnings

For External Use Only

Otc - When Using

When using this product- Avoid contact with eyes. In case of eye contact, flush with water.

Otc - Stop Use

Stop Use and ask Doctor if irritation or redness develops

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.

Dosage & Administration

Pump in hands , wet as needed- Lather vigorously for at least 15 seconds- Wash skin thoroughly and dry.

Other Safety Information

Store below 110° F (43° C)

Inactive Ingredient

Water, Cocamidopropyl Betaine, Glycerin, Decyl Glucoside, Sodium Lauroamphoacetate, Phenoxyethanol, Fragrance, DMDM Hydantoin, Disodium EDTA, Benzophenone-4, Citric Acid, CI 19140

Indications & Usage

For hand washing to decrease bacteria on the skin

* Please review the disclaimer below.