NDC 72715-001 Thumb Thumb No Thumb

Saccharum Off.

NDC Product Code 72715-001

NDC Code: 72715-001

Proprietary Name: Thumb Thumb No Thumb What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Saccharum Off. What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 72715 - Beautiful Day Organics, Llc
    • 72715-001 - Thumb Thumb No Thumb

NDC 72715-001-02

Package Description: 1 TUBE in 1 CARTON > 56 g in 1 TUBE (72715-001-01)

NDC Product Information

Thumb Thumb No Thumb with NDC 72715-001 is a a human over the counter drug product labeled by Beautiful Day Organics, Llc. The generic name of Thumb Thumb No Thumb is saccharum off.. The product's dosage form is gel and is administered via topical form.

Labeler Name: Beautiful Day Organics, 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.

Thumb Thumb No Thumb 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.


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)

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: Beautiful Day Organics, Llc
Labeler Code: 72715
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 04-12-2019 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: 12-31-2020 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.

Thumb Thumb No Thumb Product Label Images

Thumb Thumb No Thumb 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

Active IngredientSaccharum Off. (6X)..........................

Otc - Purpose


Indications & Usage

Use-May help deter thumb and finger sucking.


Warnings:For external use only.Allergy alert: Do not use if allergic to any of the ingredientsDo not use In or near the eyes.Do not apply To broken or sore skin.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If more than intended use is swallowed, getmedical help or contact a Poison Control Centerright away.

Dosage & Administration

Directions: Children 2 years and older:  Wash thumb and fingers with warm water and soap.Apply a liberal amount and rub evenly overthe entire thumb including the cuticle aroundthe fingernail.Re-apply as needed.

Inactive Ingredient

Inactive Ingredients: Bitter Green Gras, Citric Acid, PotassiumSorbate, Water (purified), Xanthan Gum.

Other Safety Information

Other Info: Store at room temperature 68-77F (20-25C).Avoid direct sunlight.

* Please review the disclaimer below.

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