THUMB THUMB NO THUMB- saccharum off. gel

Thumb Thumb No Thumb by

Drug Labeling and Warnings

Thumb Thumb No Thumb by is a Homeopathic medication manufactured, distributed, or labeled by Beautiful Day Organics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose-Deterrent

INDICATIONS & USAGE

Use-May help deter thumb and finger sucking.

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

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

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THUMB THUMB NO THUMB 
saccharum off. gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72715-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SACCHARUM OFFICINARUM WHOLE (UNII: 3Z20C92XNB) (SACCHARUM OFFICINARUM WHOLE - UNII:3Z20C92XNB)	SACCHARUM OFFICINARUM WHOLE	6 [hp_X]  in 58 g

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	yellow (colorless to pale yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72715-001-02	1 in 1 CARTON	04/12/2019
1	NDC: 72715-001-01	56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/12/2019

Labeler - Beautiful Day Organics, LLC (080738209)

Registrant - Beautiful Day Organics, LLC (080738209)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(72715-001)