Adult Dosing

Topical anesthesia, mucosal

• Apply aerosols, gels, pastes, or solutions containing 20% benzocaine tid-qid PRN

Medical device lubrication

• Apply to device before insertion; for use on nasogastric tubes, fiberoptic scopes, specula, intratracheal catheters

Minor sore throat pain

• Dissolve one benzocaine-containing lozenge in mouth and repeat as needed

Temporary relief of pain associated with dental conditions

• Apply gels, topical aerosols, or solutions containing 2.5-20% benzocaine topically as needed

Pediatric Dosing

Topical anesthesia, mucosal

• Apply aerosols, gels, pastes, or solutions containing 20% benzocaine tid-qid PRN

Medical device lubrication

• Apply to device before insertion; for use on nasogastric tubes, fiberoptic scopes, specula, intratracheal catheters

Minor sore throat pain

• Dissolve one benzocaine-containing lozenge in mouth and repeated as needed

Temporary relief of pain associated with dental conditions

• Apply gels, topical aerosols, or solutions containing 2.5-20% benzocaine topically as needed

[Outline]

• Adult Dosing
• Pediatric Dosing

• Topical anesthesia (Mucosal)
• Medical device lubrication
• Temporary relief of minor sore throat pain
• Topically with other anesthetics as a local anesthetic agent prior to surgical, endoscopic, or other procedures

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Benzocaine sprays used in the mouth and throat have been associated with methemoglobinaemia; most cases reported in patients undergoing intubation, endoscopic, or bronchoscopic procedures in hospital settings
• Severe/persistent throat pain or pain accompanied by fever, rash, headache, nausea, vomiting may be serious
• Serious adverse effects e.g., seizures, coma, irregular heart beat, respiratory depression, have been reported following topical application of local anesthetics to the skin. Apply small amount of topical anesthetic to the affected area for the shortest period necessary for the desired effect
• For external use only
• Avoid prolonged use; do not exceed recommended dosage or duration of therapy
• Use with extreme caution in pediatric patients <2 yrs of age

Cautions: Use cautiously in

• Hepatic impairment
• Thyroid disorder
• Cardiovascular disease
• Diabetes mellitus
• CNS disease
• Shock
• Asthma
• Emphysema
• COPD
• Chronic bronchitis
• Debilitated patients
• Large or severely abraded areas of skin or mucous membrane
• Pediatric population (risk of systemic toxicity; use smaller doses due to potential for methemoglobinemia)
• Geriatric population (increased risk of toxicity; use smaller doses)

Supplemental Patient Information

• For external use only; avoid contact with eyes

Pregnancy Category:C

Breastfeeding: Safety unknown.

• CNS: Seizures, coma, respiratory depression
• CV: Irregular heart beat
• LOCAL: Redness, irritation, swelling, pain, bleeding
• MISC: Fever

• Local anesthetic; decreases neuronal membrane permeability to sodium ions by reversibly stabilizing the neuronal membrane; blocks the initiation and conduction of nerve impulses
• Minimal systemic availability after topical application
• Metabolism/Excretion: Unknown
• Half life : Unknown

US Trade Name(s)

• Anbesol Jr
• Anbesol maximum strength
• Baby anbesol
• Baby orajel
• Baby orajel nighttime
• Cepacol fizzlers
• Cepacol Sensations Hydra
• Cepacol Sensations Warming
• Chloraseptic Kids Sore Throat Lollipops
• Chloraseptic Warming Sore Throat Lozenges
• Hurricaine
• Kank-a soothing beads
• Kank-a-mouth pain liquid
• Kids chloraseptic sore throat relief strips
• Little colds sore throat relief
• LIttle teethers oral pain relief gel
• Orabase
• Orajel maximum strength
• Orajel mouth sore discs
• Orajel PM maximum strength
• Orajel severe pain
• Orajel toothache swabs
• Orajel
• Oragel cold sore swabs
• Zilactin B
• Zilactin Tooth and Gum

US Availability

Anbesol Jr.

• OTC GEL: 10%

Anbesol maximum strength

• OTC GEL: 20%
• OTC LIQU: 20%

Baby anbesol

• OTC GEL: 7.5%

Baby orajel

• OTC GEL: 7.5 %
• OTC LIQU: 7.5 %
• OTC SWAB: 7.5%

Baby orajel nighttime

• OTC GEL: 10%

Cepacol fizzlers

• OTC LOZENGE: 6 mg
• OTC SPRAY: 20%

Cepacol Sensations Hydra

• OTC LOZENGE: 3 mg

Cepacol Sensations Warming

• OTC LOZENGE: 4 mg

Chloraseptic Kids Sore Throat Lollipops

• OTC LOZENGE: 6 mg

Chloraseptic Warming Sore Throat Lozenges

• OTC LOZENGE: 15 mg

Hurricaine

• OTC GEL: 20%

Kank-a-mouth pain liquid

• OTC LiQU: 20%

Kank-a soothing beads

• OTC ORAL BEAD: 3 mg

Kids chloraseptic sore throat relief strips

• OTC Disintegrating strip: 2 mg

Little colds sore throat relief

• OTC ORAL GRAN: 6 mg/pkt

LIttle teethers oral pain relief gel

• OTC GEL: 7.5%

Orabase

• OTC PASTE: 20%

Orajel, Oragel cold sore swabs

• OTC GEL: 10%

Orajel maximum strength

• OTC GEL: 20%
• OTC LIQU: 20%

Orajel mouth sore discs

• OTC Disintegrating patch: 15 mg

Orajel PM maximum strength

• OTC CRE: 20%

Orajel severe pain

• OTC GEL: 20%

Orajel toothache swabs

• OTC GEL: 20%

Zilactin B

• OTC GEL: 20%

Zilactin Tooth and Gum

• OTC SWAB: 20%

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• AAA Sore Throat Spray
• Cherry Flavour Ultra Chloraseptic Anaesthetic Throat Spray
• BurnEze Spray

UK Availability

AAA Sore Throat Spray

• Metered SPRAY: 1.5 mg

Cherry Flavour Ultra Chloraseptic Anaesthetic Throat Spray

• SPRAY: 0.71%

BurnEze Spray

• Aerosol: 1.0% w/w

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Dermatologic

Dermatologic Topical Agents

Anesthetics

Anesthesia

Dermatologic Topical Agents

Anesthetics

Drug Name: Cepacol Fizzlers (BENZOCAINE 6 mg)

Ingredient(s): N/A

Imprint: N/A

Color(s): Purple

Shape: Round

Size (mm): 9.00

Score: 1

Inactive Ingredient(s): citric acid / colloidal silicon dioxide / crospovidone / d&c red no. 27 / d&c blue no. 1 / magnesium stearate / mannitol / cellulose, microcrystalline / sodium bicarbonate / sucralose

Drug Label Author:
Combe Incorporated

DEA Schedule:
Non-Scheduled