Label: THUMB THUMB NO THUMB EXTRA STRENGTH- saccharum off. gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated December 26, 2019

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  • ACTIVE INGREDIENT

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

  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    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)
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