Oral Pain Relief Gel

Oral Pain Relief Gel
SPL v3
SPL
SPL Set ID 18520f9b-4d35-1e9c-e063-6294a90aaa39
Route
TOPICAL
Published
Effective Date 2024-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (0.2 g) Benzalkonium (0.01 g)
Inactive Ingredients
Ammonium Glycyrrhizate Polyethylene Glycol, Unspecified Saccharin Sodium Sorbic Acid Water Fd&c Yellow No. 5 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-05

Description

Benzocaine 20% Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever Antiseptic


Medication Information

Purpose

Oral pain reliever

Antiseptic

Description

Benzocaine 20% Benzalkonium Chloride 0.1%

Use

■ for the temporary relief of pain due to toothaches

■ to help protect against infection in minor oral irritation

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce 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

• fatigue or lack of energy

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

Directions

■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider

■ children under 12 years of age: should be supervised in the use of this product

■ children under 2 years of age: Do not use

Do Not Use

■ more than directed

■ for more than 7 days unless directed by a physician or healthcare provider

Package Label

Oral Pain Relief Gel

NET WT. 0.5 oz (14 g)

Other Information

■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a physican can be consulted

■ do not use continuously

■ avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Active Ingredients

Benzocaine 20%

Benzalkonium Chloride 0.1%

Inactive Ingredients

ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid, purified water, FD&C Yellow#5, FD&C Red#40

Keep Out of Reach of Children

In case of overdose or allergic reaction get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Physician If

■ swelling, rash or fever develops

■ irritation, pain or redness persists or worsens

■ symptoms do not improve in 7 days


Structured Label Content

Use

■ for the temporary relief of pain due to toothaches

■ to help protect against infection in minor oral irritation

Purpose

Oral pain reliever

Antiseptic

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce 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

• fatigue or lack of energy

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

Directions

■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider

■ children under 12 years of age: should be supervised in the use of this product

■ children under 2 years of age: Do not use

Do Not Use (Do not use)

■ more than directed

■ for more than 7 days unless directed by a physician or healthcare provider

Package Label

Oral Pain Relief Gel

NET WT. 0.5 oz (14 g)

Other Information (Other information)

■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a physican can be consulted

■ do not use continuously

■ avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying

■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Active Ingredients

Benzocaine 20%

Benzalkonium Chloride 0.1%

Inactive Ingredients (Inactive ingredients)

ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid, purified water, FD&C Yellow#5, FD&C Red#40

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.

Stop Use and Ask A Physician If (Stop use and ask a physician if)

■ swelling, rash or fever develops

■ irritation, pain or redness persists or worsens

■ symptoms do not improve in 7 days


Advanced Ingredient Data


Raw Label Data

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