Otc - Active Ingredient
Benzocaine 20%
Menthol 0.26%
Zinc chloride 0.15%
Dg 3x Medicated Toothache Adn Gum Gel
FDA Label NDC 55910-816
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dollar General for the product Dg 3x Medicated Toothache Adn Gum Gel (NDC 55910-816). 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, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Oral pain reliever
Oral pain reliever
Oral astringent
Indications & Usage
for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums
Warnings
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics
Do not use * more than directed * for more than 7 days uness told to do so by a dentist or doctor * for teething * in children under 2 years of age
Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergeic reaction occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
Dosage & Administration
cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of product to teh cavity and around the gum surrounding the teeth * use up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use
Other Safety Information
do not use if tip is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted * do not use continuously * this formula will stay in place for extended duration of relief * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying * retain carton for complete product information
Inactive Ingredient
ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid
* Please review the disclaimer below.
