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Drug Facts
DISTRIBUTED BY:
PUBLIX SUPER MARKETS, 3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811
4x Medicated Toothache And Gum Gel Gel, Dentifrice
FDA Label NDC 56062-312
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets Inc for the product 4x Medicated Toothache And Gum Gel (NDC 56062-312). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Benzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.5%
Zinc Chloride 0.15%
Otc - Purpose
Oral antiseptic
Oral pain reliever
Oral astringent
Indications & Usage
temporary relief of pain due to toothache * to help protect against infection of minor oral irritation
Warnings
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
pale, gray, or blue colored skin (cyanosis)
headache
rapid heart rate
shortness of breath
dizziness or lightheadness
fatique or lack of energy
Alergy 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
Otc - Do Not Use
Do not use:
more than directed
for more than 7 days unless directed by a dentist or doctor
for teething
in children under 2 years of age
Otc - Stop Use
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
allergic reaction occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
cut open tip of tube on score mark
adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor.
children between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product
children under 2 years of age: do not use
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
Inactive Ingredient
ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid
Package Label.Principal Display Panel
PUBLIX SUPER MARKETS, INC
4X MEDICATED GEL
TOOTHACHE & GUM PAIN RELIEF
- 20% Benzocaine to relieve oral pain
- Kills harmful bacteria
- Astringent to help prevent infection
- Cools gum & relieves irritation
Compare to the active ingredients in Orajel
4X medicated for toothache & Gum gel*
NET WT 0.25OZ (7 g)
* Please review the disclaimer below.
