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benzocaine/menthol oropharyngeal (Orajel Severe Toothache Pain Relief, Orajel Severe PM Toothache Pain Relief, Cepacol Sensations Cooling)

 

Classes: Anesthetics, Oropharyngeal

Dosing and uses of Orajel Severe Toothache Pain Relief, Orajel Severe PM Toothache Pain Relief (benzocaine/menthol oropharyngeal)

 

Adult dosage forms and strengths

benzocaine/menthoL

oropharyngeal cream/geL

  • 20%/0.25% (Orajel)

lozenge

  • 4mg/9mg (Cepacol Sensations Cooling)

 

Toothache

Indicated for temporary relief of pain due to toothaches

Apply small amount to cavity and around gum surrounding the teeth QID PRn

 

Pediatric dosage forms and strengths

benzocaine/menthoL

oropharyngeal cream/geL

  • 20%/0.25% (Orajel)

lozenge

  • 4mg/9mg (Cepacol Sensations Cooling)

 

Toothache

Indicated for temporary relief of pain due to toothaches

<2 years: Safety and efficacy not established

2 years or older: Apply small amount to cavity and around gum surrounding the teeth QID PRn

 

Warnings

Contraindications

Hypersensitivity to benzocaine or other anesthetic esters (eg, procaine)

 

Cautions

Discontinue if swelling, rash, or fever develops

Discontinue if irritation, pain, or redness persist or worsens, or if symptoms do not improve in 7 days

Do not use for >7 days unless directed by dentist/physician

 

Pregnancy and lactation

Pregnancy category: C

Lactation: not known if distributed in milk

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Orajel Severe Toothache Pain Relief, Orajel Severe PM Toothache Pain Relief (benzocaine/menthol oropharyngeal)

Mechanism of action

Benzocaine and menthol are topical anesthetics that reversibly block nerve conduction near their site of administration, thereby producing temporary loss of sensation in a limited area

 

Absorption

Bioavailability: Skin and mucosal absorption is highly variable; most anesthetic agents exist as solids and are only superficially absorbed through intact skin