FDA Label for Dg 3x Medicated Toothache Adn Gum Gel
View Indications, Usage & Precautions
Dg 3x Medicated Toothache Adn Gum Gel Product Label
The following document was submitted to the FDA by the labeler of this product Dollar General. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Benzocaine 20%
Menthol 0.26%
Zinc chloride 0.15%
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
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