Thumb Thumb No Thumb Extra Strength

Manufacturer: Beautiful Day Organics, LLC | ULTRAtab Laboratories, Inc.
Effective date: 2019-12-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:11:56

Label at a glance#

ProductThumb Thumb No Thumb Extra Strength

Active ingredientSACCHARUM OFFICINARUM WHOLE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Saccharum Off. (6X)..........................

INDICATIONS & USAGE SECTION

Use-May help deter thumb and finger sucking.

WARNINGS SECTION

Warnings:For external use only.
Allergy alert: Do not use if allergic to any of the ingredients

Do not use In or near the eyes.
Do not apply To broken or sore skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If more than intended use is swallowed, get
medical help or contact a Poison Control Center
right away.

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72715-002-02	2023-01-30	C162847	48780-1	f386c649-edc6-0266-e053-dadaa90a7c1a	Dug Fcts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72715-002-01	Thumb Thumb No Thumb Extra Strength	56 g in 1 TUBE	GEL	56		1
72715-002-02	Thumb Thumb No Thumb Extra Strength	1 in 1 CARTON	GEL	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72715-002	THUMB THUMB NO THUMB EXTRA STRENGTH (SACCHARUM OFF.) GEL [BEAUTIFUL DAY ORGANICS, LLC]	1	Legacy NDC, 2 package rows	20191231_590e6e31-f2ca-41e3-b4c0-f9aca49f7c0a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Thumb Thumb No Thumb Extra Strength
Saccharum off.
SACCHARUM OFFICINARUM WHOLE
POTASSIUM SORBATE
WATER
CITRIC ACID MONOHYDRATE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72715-002	72715-002-01, 72715-002-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SACCHARUM OFFICINARUM WHOLE	3Z20C92XNB	ACTIR
POTASSIUM SORBATE	1VPU26JZZ4	IACT
WATER	059QF0KO0R	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
XANTHAN GUM	TTV12P4NEE	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
28df67fe-1940-455d-ae00-43a9e6aed927			590e6e31-f2ca-41e3-b4c0-f9aca49f7c0a	2019-12-26	Warnings	Exact identifier spl id: 28df67fe-1940-455d-ae00-43a9e6aed927 spl set id: 590e6e31-f2ca-41e3-b4c0-f9aca49f7c0a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.