5820631 Publix 4x Medicated Toothache & Gum Gel (8015602)
16eb9d15-dba3-36e6-e063-6394a90ab859
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Warnings and Precautions
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
Indications and Usage
temporary relief of pain due to toothache * to help protect against infection of minor oral irritation
Dosage and 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
Description
Drug Facts
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.
Section 50566-9
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
Section 50570-1
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
Section 51727-6
ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid
Section 51945-4
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)
Section 55105-1
Oral antiseptic
Oral pain reliever
Oral astringent
Section 55106-9
Benzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.5%
Zinc Chloride 0.15%
Structured Label Content
Indications and Usage (34067-9)
temporary relief of pain due to toothache * to help protect against infection of minor oral irritation
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
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
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
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
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid
Section 51945-4 (51945-4)
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)
Section 55105-1 (55105-1)
Oral antiseptic
Oral pain reliever
Oral astringent
Section 55106-9 (55106-9)
Benzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.5%
Zinc Chloride 0.15%
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:44.494693 · Updated: 2026-03-14T23:09:41.311223