Oral Gel

Oral Gel
SPL v2
SPL
SPL Set ID 05ede7e4-5a0a-c942-e063-6294a90a8a24
Route
TOPICAL
Published
Effective Date 2014-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g) Benzalkonium (0.1 g)
Inactive Ingredients
Ammonium Glycyrrhizate Polyethylene Glycol, Unspecified Saccharin Sodium Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-22

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 infectionin minor oral irritation

Warnings

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: should be supervised in the use of this product ■ children under 2 years of age: ask a physician or health care provider

Do Not Use

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

Package Label

Active Ingredient

Benzocaine 20%

Benzalkonium Chloride 0.1%

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

Inactive Ingredients

ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

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 infectionin minor oral irritation

Purpose

Oral pain reliever

Antiseptic

Warnings

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: should be supervised in the use of this product ■ children under 2 years of age: ask a physician or health care provider

Do Not Use (Do not use)

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

Package Label

Active Ingredient

Benzocaine 20%

Benzalkonium Chloride 0.1%

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

Inactive Ingredients (Inactive ingredients)

ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

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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