NDC 55814-102 Organic Hand Sanitizer Peppermint

Alcohol

NDC Product Code 55814-102

NDC Product Information

Organic Hand Sanitizer Peppermint with NDC 55814-102 is a a human over the counter drug product labeled by Dr. Bronner's Magic Soaps. The generic name of Organic Hand Sanitizer Peppermint is alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Dr. Bronner's Magic Soaps

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

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Organic Hand Sanitizer Peppermint Active Ingredient(s)

Additional informationCallout TooltipWhat 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 62 mL/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • PEPPERMINT OIL (UNII: AV092KU4JH)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dr. Bronner's Magic Soaps
Labeler Code: 55814
FDA Application Number: part333E Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-03-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Organic Hand Sanitizer Peppermint Product Label Images

Organic Hand Sanitizer Peppermint 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 Ingredients:

ETHYL ALCOHOL (ORGANIC) 62%

Purpose:

ANTISEPTIC

Uses:

FOR HAND WASHING TO DECREASE BACTERIA ON SKIN.

Warnings:

FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

Inactive Ingredients

WATER, ORGANIC GLYCERIN, ORGANIC PEPPERMINT OIL

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.

Otc - Do Not Use

DO NOT USE NEAR EYES. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION DEVELOPS.

Directions

SPRAY ON PALM, RUB HANDS TOGETHER. SUPERVISE CHILDREN UNDER 6.

Other Information

STORE AT 20° - 25°C (68° - 77°F)

Questions?

CALL 760-743-2211

* Please review the disclaimer below.

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