Comfortcaine

Comfortcaine
SPL v7
SPL
SPL Set ID 831b7c11-e437-4e74-808e-c9c1eb8b82f6
Route
TOPICAL
Published
Effective Date 2024-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Vera Leaf Water Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Edetate Disodium Sodium Hydroxide Caprylyl Glycol Phenoxyethanol Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-11-12
Description

Lidocaine Hydrochloride (4% w/w)

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Lidocaine Hydrochloride (4% w/w)

Section 51945-4

​uses

• For the temporary relief of pain associated with minor burns, sunburn, scrapes, or minor skin irritations.

​purpose

Topical Analgesic

​warnings

• For external use only.

• Avoid contact with the eyes.

• ​Do not use​ ​in large quantities, particularly over raw surfaces or blistered areas.

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

​directions

• Adults and children 2 years of age or older: Apply to affected area not more than 3 or 4 times daily.  Children under 2 years of age: consult a physician.

Other Information

• Store at room temperature 15-30°C (59-86°F)

​active Ingredients

Lidocaine Hydrochloride (4% w/w)

​inactive Ingredients:

Aloe Barbadensis Leaf Extract, Water, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Yellow No 5, FD&C Blue No 1.

​questions Or Comments?

1-800-445-2563

​keep Out of Reach of Children

• If accidentally ingested contact a physician or Poison Control Center immediately.

Structured Label Content

Section 51945-4 (51945-4)

​uses (​Uses)

• For the temporary relief of pain associated with minor burns, sunburn, scrapes, or minor skin irritations.

​purpose (​Purpose)

Topical Analgesic

​warnings (​Warnings)

• For external use only.

• Avoid contact with the eyes.

• ​Do not use​ ​in large quantities, particularly over raw surfaces or blistered areas.

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

​directions (​Directions)

• Adults and children 2 years of age or older: Apply to affected area not more than 3 or 4 times daily.  Children under 2 years of age: consult a physician.

Other Information

• Store at room temperature 15-30°C (59-86°F)

​active Ingredients (​Active Ingredients)

Lidocaine Hydrochloride (4% w/w)

​inactive Ingredients: (​Inactive Ingredients:)

Aloe Barbadensis Leaf Extract, Water, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Yellow No 5, FD&C Blue No 1.

​questions Or Comments? (​Questions or comments?)

1-800-445-2563

​keep Out of Reach of Children (​Keep out of reach of children)

• If accidentally ingested contact a physician or Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:31.481612 · Updated: 2026-03-14T23:13:34.159935