Otc - Active Ingredient
Active Ingredient
Saccharum Off. (6X)..........................
Thumb Thumb No Thumb Extra Strength
FDA Label NDC 72715-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beautiful Day Organics, Llc for the product Thumb Thumb No Thumb Extra Strength (NDC 72715-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, other safety information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - 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.
Package Label.Principal Display Panel
Image Description (Extrastrenghtcarton)
* Please review the disclaimer below.
