Dosing and uses of Orajel Single Dose (benzalkonium chloride/benzocaine)
Adult dosage forms and 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
Pediatric dosage forms and 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
Orajel Single Dose (benzalkonium chloride/benzocaine) adverse (side) effects
Frequency not defined
Temporary stinging at application site
Warnings
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 and 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.
Pharmacology of Orajel Single Dose (benzalkonium chloride/benzocaine)
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
