Body & Beauty / Compounds / Benzocaine

Benzocaine on your skin: a safety profile

Low risk

Topical application on intact skin has low systemic absorption. Contact sensitization is the primary concern.

What is benzocaine?

Benzocaine is a local anesthetic, ester-type anesthetic, OTC topical analgesic.

The IUPAC name is ethyl 4-aminobenzoate.

Also known as: ethyl 4-aminobenzoate, ethyl p-aminobenzoate, Americaine, Orajel (active ingredient).

IUPAC name: ethyl 4-aminobenzoate
CAS number: 94-09-7
Molecular formula: C9H11NO2
Molecular weight: 165.19 g/mol
SMILES: CCOC(=O)C1=CC=C(N)C=C1
PubChem CID: 2337

Risk for people

Low risk

Topical application on intact skin has low systemic absorption. Contact sensitization is the primary concern.

Benzocaine is a known contact sensitizer (para-amino group). Allergic contact dermatitis can develop after repeated use. Cross-reactivity with other para-amino compounds (PABA, sulfonamides, certain hair dyes) is documented.

What to do: Patch test if history of contact allergies. Discontinue if rash or allergic reaction develops.

Regulatory consensus

4 regulatory and scientific bodies have classified Benzocaine. The classifications differ — that's the data.

Agency	Year	Classification	Notes
FDA	2018	OTC monograph drug; contraindicated in children under 2 years	FDA Drug Safety Communication (2018): required label changes to warn against use in children younger than 2 years. Multiple safety communications since 2006.
EU Cosmetics Regulation	—	Permitted in cosmetics at max 0.5%	EU Cosmetics Regulation (EC) No 1223/2009 — permitted as topical anesthetic in cosmetic products at limited concentration
MHRA (UK)	—	Restricted OTC teething use	UK MHRA restricted OTC availability of benzocaine teething products following FDA safety communications
Health Canada	—	Restricted OTC teething use	Health Canada issued safety review and restricted benzocaine use in children under 2

Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.

Where you encounter benzocaine

Oral Pain Relief — Orajel, Anbesol, Hurricaine gel, dental topical anesthetics
Primary OTC use — oral mucosal analgesia for toothache, canker sores, denture pain
Teething Products — Baby Orajel (discontinued/reformulated), teething gels
FDA contraindicated for children under 2 years since 2018
Sunburn Relief — Dermoplast, Solarcaine, sunburn relief sprays
Topical spray formulations for minor burn pain relief
Throat Products — Cepacol lozenges, sore throat sprays, cough drops
Used as local anesthetic in throat lozenges and sprays
Personal Products — desensitizing condoms, premature ejaculation delay products
Used at low concentrations (5-7.5%) as topical desensitizer

Safer alternatives

Lower-risk approaches that achieve a similar outcome to Benzocaine:

Lidocaine (amide-type, lower methemoglobinemia risk)
Chilled teething rings (non-pharmacologic, for infants)
Ibuprofen or acetaminophen (systemic analgesics for teething pain in age-appropriate children)

Frequently asked questions

Is benzocaine safe for you?

Topical application on intact skin has low systemic absorption. Contact sensitization is the primary concern.

What products contain benzocaine?

Benzocaine appears in: Orajel (oral pain relief); Anbesol (oral pain relief); Baby Orajel (discontinued/reformulated) (teething products); teething gels (teething products); Dermoplast (sunburn relief).

What should I do if my you is exposed to benzocaine?

Patch test if history of contact allergies. Discontinue if rash or allergic reaction develops.

Why do regulators disagree about benzocaine?

Benzocaine has been classified by 4 agencies including FDA, EU Cosmetics Regulation, MHRA (UK), Health Canada, with differing conclusions. Regulators apply different standards of evidence (animal data weighting, exposure-pattern assumptions, epidemiological power thresholds), which is why two scientific bodies can review the same data and reach different conclusions. See the regulatory consensus table on this page for the full picture.

See Benzocaine in the body app

Look up products containing benzocaine, compare to alternatives, and explore the full data record.

Open in body View raw API data

Sources (4)

— regulatory_database
— regulatory_agency
— safety_data_sheet
— expert_curation

Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →