THUMB THUMB NO THUMB EXTRA STRENGTH- saccharum off. gel 
Beautiful Day Organics, LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Dug Fcts

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

Use-May help deter thumb and finger sucking.

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.

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

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

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

image description

THUMB THUMB NO THUMB EXTRA STRENGTH 
saccharum off. gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72715-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SACCHARUM OFFICINARUM WHOLE (UNII: 3Z20C92XNB) (SACCHARUM OFFICINARUM WHOLE - UNII:3Z20C92XNB) SACCHARUM OFFICINARUM WHOLE6 [hp_X]  in 58 g
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Coloryellow (colorless to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72715-002-021 in 1 CARTON12/26/2019
1NDC:72715-002-0156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/26/2019
Labeler - Beautiful Day Organics, LLC (080738209)
Registrant - Beautiful Day Organics, LLC (080738209)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(72715-002)

Revised: 12/2019
Document Id: 28df67fe-1940-455d-ae00-43a9e6aed927
Set id: 590e6e31-f2ca-41e3-b4c0-f9aca49f7c0a
Version: 1
Effective Time: 20191226
 
Beautiful Day Organics, LLC