Orajel Single Dose (benzalkonium chloride/benzocaine) dosing, indications, interactions, adverse effects, and more

Sections

Sections benzalkonium chloride/benzocaine
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

benzalkonium chloride/benzocaine

topical solution (touch-free applicator)

0.13%/5%

Cold Sores

Orajel Single Dose: Apply single dose topically to cold sore (see administration)

Administration

Orajel Single Dose

Clean lip area using only warm water or alcohol of any lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick
Follow directions on applicator to allow medication to saturate the tip
Gently touch the site of the cold sore with the saturated applicator tip; once the area is numb, rub the site of the cold sore and the surrounding area
Rub firmly to allow the treatment to deeply penetrate the skin
To treat most cold sores, 1 treatment is typically enough, if symptoms go away and then return, apply another dose for the second cold sore
Do not exceed ≥3 applications/day
Discard after use

Dosage Forms & Strengths

benzalkonium chloride/benzocaine

topical solution (touch-free applicator)

0.13%/5%

Cold Sores

<2 years: Safety and efficacy not established

Orajel Single Dose (≥2 years): Apply single dose topically to cold sore (see administration)

Administration

Orajel Single Dose

Clean lip area using only warm water or alcohol of any lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick
Follow directions on applicator to allow medication to saturate the tip
Gently touch the site of the cold sore with the saturated applicator tip; once the area is numb, rub the site of the cold sore and the surrounding area
Rub firmly to allow the treatment to deeply penetrate the skin
To treat most cold sores, 1 treatment is typically enough, if symptoms go away and then return, apply another dose for the second cold sore
Do not exceed ≥3 applications/day
Discard after use

Frequency Not Defined

Temporary stinging at application site

Contraindications

Hypersensitivity

Cautions

For external use only

Flammable, keep away from fire or flame

Stop and contact dentist or physician is symptoms persist >7 days

Ingredients in toothpaste, soft drinks, and some fruit juices can deactivate active ingredient

Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown whether distributed in breast 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.

Mechanism of Action

Benzalkonium chloride: Topical antiseptic

Benzocaine: Topical anesthetic; decreases the neuronal membrane's permeability to sodium ions, which inhibits depolarization and subsequently blocks conduction of nerve impulses

Also contains 70% isopropyl alcohol

BRAND	FORM.	UNIT PRICE	PILL IMAGE
Unguentine topical -	6.6-3-2.5-2.2 % ointment

Patient Handout

A Patient Handout is not currently available for this monograph.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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