5820631 Publix 4x Medicated Toothache & Gum Gel (8015602)

5820631 Publix 4x Medicated Toothache & Gum Gel (8015602)
SPL v5
SPL
SPL Set ID 16eb9d15-dba3-36e6-e063-6394a90ab859
Route
ORAL
Published
Effective Date 2024-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g) Benzalkonium (0.13 g) Zinc Cation (0.15 g) Menthol (0.5 g)
Inactive Ingredients
Polyethylene Glycol 3350 Fd&c Blue No. 1 Sorbic Acid Polyethylene Glycol 400 Methyl Salicylate Saccharin Sodium Ammonium Glycyrrhizate

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-01

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

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