5820614 Ra 4x Cream

5820614 Ra 4x Cream
SPL v14
SPL
SPL Set ID 996fdbeb-1fe3-77b6-e053-2995a90a25c7
Route
ORAL
Published
Effective Date 2020-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g) Menthol (0.26 g) Zinc Cation (0.15 g) Benzalkonium (0.13 g)
Inactive Ingredients
Saccharin Titanium Dioxide Glycyrrhizin Polyethylene Glycol 3350 Polyethylene Glycol 400 Sorbic Acid

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-06 Until 2027-01-01

Description

Active Ingredient Purpose Belkonium chloride 0.13% .... Oral antiseptic Benzocaine 20% ................... Oral pain reliever Menthol 0.26% ...................... Oral pain reliever Zinc chloride 0.15% ............... Oral astringent


Medication Information

Indications and Usage

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces teh 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 lightheadedness * fatigue or lack of energy

Description

Active Ingredient Purpose Belkonium chloride 0.13% .... Oral antiseptic Benzocaine 20% ................... Oral pain reliever Menthol 0.26% ...................... Oral pain reliever Zinc chloride 0.15% ............... Oral astringent

Use

Use * for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation

Section 50565-1

Keep out of reach of children. In case of overdose, 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 * symtoms do not improve in 7 days * allergic reaction occurs

Section 50570-1

Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age

Section 51727-6

Inactive ingredients ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

Section 51945-4

Section 55106-9

Active Ingredient Purpose

Belkonium chloride 0.13% .... Oral antiseptic

Benzocaine 20% ................... Oral pain reliever

Menthol 0.26% ...................... Oral pain reliever

Zinc chloride 0.15% ............... Oral astringent

Section 60561-8

Other information * do not use if the 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

Directions

Directions * cut open tip of tube on score mark * dults and children 2 years of age and older; apply a small amount of product to the cavity and around teh 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

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


Structured Label Content

Use

Use * for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation

Indications and Usage (34067-9)

Warnings

Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces teh 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 lightheadedness * fatigue or lack of energy

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, 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 * symtoms 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 told to do so by a dentist or doctor * for teething * in children under 2 years of age

Section 51727-6 (51727-6)

Inactive ingredients ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredient Purpose

Belkonium chloride 0.13% .... Oral antiseptic

Benzocaine 20% ................... Oral pain reliever

Menthol 0.26% ...................... Oral pain reliever

Zinc chloride 0.15% ............... Oral astringent

Section 60561-8 (60561-8)

Other information * do not use if the 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

Directions

Directions * cut open tip of tube on score mark * dults and children 2 years of age and older; apply a small amount of product to the cavity and around teh 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

Allergy Alert (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


Advanced Ingredient Data


Raw Label Data

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